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IEC 62353 Recurrent Test Service (In-Service Testing) in Cabo Verde
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IEC 62353 Recurrent Test Service (In-Service Testing) High-standard technical execution following OEM protocols and local regulatory frameworks.
Ensuring Patient Safety through IEC 62353 Compliance
Our IEC 62353 recurrent testing service in Cabo Verde guarantees that all medical electrical equipment is rigorously tested for safety in accordance with international standards. This proactive approach identifies and mitigates potential risks, safeguarding patients and healthcare professionals from electrical hazards.
Optimizing Medical Equipment Performance and Reliability
Beyond safety, our IEC 62353 testing service in Cabo Verde extends to verifying the functional performance and reliability of medical electrical equipment. This ensures that devices operate optimally, minimizing downtime and supporting consistent, high-quality patient care throughout their operational lifespan.
Standardized and Documented In-Service Testing Protocols
We provide Cabo Verde's healthcare facilities with a standardized and meticulously documented recurrent testing service adhering to IEC 62353. Our comprehensive reports offer clear evidence of compliance, facilitating regulatory audits, asset management, and informed decision-making for equipment maintenance and replacement strategies.
What Is Iec 62353 Recurrent Test Service (In-service Testing) In Cabo Verde?
IEC 62353, "Medical electrical equipment – Routine checks and tests after repair of medical electrical equipment," provides a standardized framework for ensuring the safety and performance of medical electrical equipment throughout its lifecycle. In Cabo Verde, as internationally, the IEC 62353 Recurrent Test Service, also known as In-Service Testing, refers to the systematic performance of safety and functional tests on medical electrical equipment after it has been put into service. This is distinct from initial commissioning tests or tests performed solely after a repair. The primary objective is to verify that the equipment continues to meet established safety and performance standards, thereby mitigating risks to patients, operators, and the environment. This service is crucial for maintaining the integrity of medical devices, preventing failures, and ensuring compliance with regulatory requirements.
| Who Needs IEC 62353 Recurrent Test Service in Cabo Verde? | Typical Use Cases |
|---|---|
| Hospitals and Clinics (Public and Private): All healthcare facilities utilizing medical electrical equipment. | Routine verification of defibrillators and cardiac monitors to ensure readiness in emergencies. |
| Diagnostic Imaging Centers (X-ray, CT, MRI): Ensuring the continued safety and accuracy of high-risk diagnostic equipment. | Periodic assessment of anesthesia machines to guarantee precise delivery of anesthetic gases. |
| Surgical Centers and Operating Theaters: Maintaining the integrity of life-support and monitoring equipment. | Testing of electrosurgical units to confirm insulation integrity and prevent unintended tissue damage. |
| Laboratories and Blood Banks: Verifying the performance of laboratory equipment and blood storage devices. | Annual checks on infusion pumps to confirm accurate dosage delivery. |
| Medical Device Manufacturers (for their own deployed equipment): Ensuring their products remain compliant and safe post-installation. | Verification of sterilizers to ensure effective sterilization cycles. |
| Regulatory Bodies and Health Authorities: For oversight and enforcement of medical device safety standards. | Evaluation of ventilators to ensure proper respiratory support. |
| Third-Party Maintenance Providers: Offering specialized testing services to healthcare facilities. | Confirmation of electrical safety for patient monitoring systems in intensive care units. |
Key Aspects of IEC 62353 Recurrent Test Service
- Purpose: To ensure ongoing safety and performance of medical electrical equipment throughout its operational life.
- Frequency: Determined by the manufacturer's recommendations, national regulations, risk assessment, and the equipment's criticality and usage. Often conducted annually or biennially.
- Scope: Encompasses electrical safety tests (e.g., protective earth resistance, enclosure leakage current, patient leakage current) and functional performance tests relevant to the equipment's intended use.
- Methodology: Follows the test procedures outlined in IEC 62353, which often leverage methods and limits defined in related IEC standards (e.g., IEC 60601 series).
- Documentation: Requires meticulous record-keeping of test results, deviations, and corrective actions, forming a crucial part of the equipment's maintenance history.
- Personnel: Must be conducted by qualified and competent personnel, typically biomedical engineers or technicians with specialized training and access to calibrated test equipment.
Who Needs Iec 62353 Recurrent Test Service (In-service Testing) In Cabo Verde?
IEC 62353 recurrent test service, also known as in-service testing, is a crucial safety standard for medical electrical equipment. This standard ensures that medical devices remain safe to operate after they have been in use for a period of time. For Cabo Verde, a nation increasingly reliant on modern healthcare infrastructure, ensuring the safety and reliability of its medical equipment is paramount for patient care. This service is essential for healthcare facilities to comply with international safety regulations, maintain equipment functionality, and prevent potential hazards to both patients and healthcare professionals. Regular testing helps identify any degradation in safety features, such as insulation resistance, protective earthing, and leakage currents, which can occur due to usage, environmental factors, or minor damage.
| Customer Type | Relevant Departments/Roles | Key Needs/Benefits |
|---|---|---|
| Hospitals (Public and Private) | Biomedical Engineering Department, Clinical Engineering Department, Quality Assurance Department, Maintenance Department, Department Heads (e.g., Cardiology, Radiology, Surgery) | Ensuring patient safety, regulatory compliance, minimizing equipment downtime, optimizing equipment lifespan, reducing risk of medical errors due to faulty equipment, protecting staff and patients from electrical hazards. |
| Clinics and Health Centers | Practice Managers, Lead Clinicians, Maintenance Personnel (if applicable) | Maintaining a safe environment for patients and staff, adhering to basic safety standards, ensuring reliability of essential diagnostic and therapeutic equipment. |
| Diagnostic Laboratories | Laboratory Managers, Technical Directors, Equipment Maintenance Staff | Guaranteeing the accuracy and reliability of diagnostic equipment, preventing false results due to electrical faults, ensuring safe operation of complex laboratory machinery. |
| Dental Practices | Dental Practice Owners, Lead Dentist, Practice Managers | Ensuring the safety of dental chairs, X-ray units, sterilization equipment, and other electrical dental tools for both patients and dental professionals. |
| Rehabilitation Centers | Center Directors, Therapy Supervisors, Equipment Technicians | Verifying the safety of therapeutic equipment such as electrical stimulation devices, treadmills, and specialized treatment apparatus. |
| Emergency Medical Services (Ambulance Services) | Operations Managers, Fleet Managers, Biomedical Technicians (if in-house) | Confirming the continuous safety and functionality of life-support equipment (defibrillators, ventilators) and other critical devices used in mobile environments. |
| Medical Equipment Suppliers and Distributors | After-Sales Service Department, Technical Support, Field Service Engineers | Offering compliant and professional recurrent testing services to their clients as part of maintenance contracts or standalone offerings, building trust and customer loyalty, ensuring their supplied equipment remains safe throughout its lifecycle. |
| Government Health Ministries and Regulatory Bodies | Medical Device Regulation Department, Health Facilities Oversight, Public Health Divisions | Establishing and enforcing safety standards for healthcare facilities, conducting audits, promoting a culture of safety, potentially mandating recurrent testing as part of licensing or accreditation processes. |
Target Customers and Departments for IEC 62353 Recurrent Test Service in Cabo Verde
- Hospitals (Public and Private)
- Clinics and Health Centers
- Diagnostic Laboratories
- Dental Practices
- Rehabilitation Centers
- Emergency Medical Services (Ambulance Services)
- Medical Equipment Suppliers and Distributors (for their service departments)
- Government Health Ministries and Regulatory Bodies
Iec 62353 Recurrent Test Service (In-service Testing) Process In Cabo Verde
This document outlines the typical workflow for IEC 62353 recurrent test services (also known as in-service testing or periodic safety testing) for medical devices in Cabo Verde. This process ensures that medical equipment remains safe and compliant with international standards after initial installation and throughout its operational life. The workflow generally begins with an inquiry from a healthcare facility or service provider and concludes with the submission of a comprehensive test report and the issuance of a compliance certificate.
| Stage | Description | Key Activities | Responsible Parties | Typical Duration |
|---|---|---|---|---|
| Inquiry and Initial Consultation | The healthcare facility or service provider expresses interest in IEC 62353 recurrent testing services. This stage involves understanding the client's needs and the types of medical devices requiring testing. | Contacting the testing service provider, discussing testing requirements, clarifying the purpose of the testing (e.g., regulatory compliance, patient safety assurance). | Client (Healthcare Facility/Service Provider), Testing Service Provider | 1-3 business days |
| Scope Definition and Quotation | Based on the initial consultation, a detailed scope of work is defined, including the specific medical devices to be tested, the test procedures to be followed (as per IEC 62353), and the deliverables. A formal quotation is then prepared. | Listing all devices for testing, identifying relevant standards and test methods, outlining the service inclusions and exclusions, preparing a cost estimate and proposal. | Testing Service Provider, Client | 2-5 business days |
| Scheduling and Logistics | Once the quotation is accepted, a mutually agreeable date and time for the on-site testing are scheduled. This includes coordinating access to the facility and ensuring the availability of the medical devices. | Communicating with facility management to book the testing slot, arranging for technician travel and accommodation (if required), ensuring devices are accessible and ready for testing. | Testing Service Provider, Client | Variable (depends on availability and client's urgency) |
| On-Site Testing Execution | Qualified and accredited technicians perform the in-service testing according to the IEC 62353 standard. This involves a series of electrical safety and functional tests. | Visual inspection, earth resistance testing, insulation resistance testing, leakage current measurements (earth, enclosure, patient), functional testing of safety mechanisms, recording of test results. | Testing Service Provider (Accredited Technicians) | Varies significantly based on the number and complexity of devices (e.g., a few hours to several days) |
| Documentation and Reporting | All test results are meticulously documented. A comprehensive test report is generated, detailing the tests performed, the results obtained, and any deviations from the standard. | Compiling raw test data, analyzing results, creating a detailed test report including device information, test parameters, measurements, and conclusions. | Testing Service Provider | 3-7 business days after testing completion |
| Follow-up and Remediation (if necessary) | If any of the tested medical devices fail to meet the IEC 62353 compliance criteria, a report is issued highlighting the issues. Recommendations for remediation or repair may be provided. If the client chooses, the testing service provider may offer repair services or recommend accredited third-party repair services. | Communicating test failures and findings, discussing potential solutions and remediation strategies, re-testing after repairs (if applicable). | Testing Service Provider, Client | Variable (depends on the complexity of remediation and client's decision) |
| Certification and Record Keeping | Upon successful completion of all tests and any necessary remediation, a compliance certificate is issued, confirming that the medical devices meet the requirements of IEC 62353. Both the testing service provider and the client maintain records of the testing. | Issuing a formal compliance certificate, archiving test reports and certificates, providing digital or hard copies to the client. | Testing Service Provider, Client | Included with the final report; ongoing record keeping |
IEC 62353 Recurrent Test Service Workflow in Cabo Verde
- Inquiry and Initial Consultation
- Scope Definition and Quotation
- Scheduling and Logistics
- On-Site Testing Execution
- Documentation and Reporting
- Follow-up and Remediation (if necessary)
- Certification and Record Keeping
Iec 62353 Recurrent Test Service (In-service Testing) Cost In Cabo Verde
The cost of IEC 62353 recurrent testing services (also known as in-service testing or periodic safety testing) for medical equipment in Cabo Verde can vary significantly based on several factors. These tests are crucial for ensuring the continued safety and functionality of medical devices after they have been put into service.
Pricing Factors:
- Type and Complexity of Medical Equipment: More complex and sophisticated medical devices (e.g., MRI machines, ventilators, anesthesia machines) require more time, specialized knowledge, and potentially more expensive testing equipment, leading to higher costs. Simpler devices like standard examination tables or basic diagnostic tools will be less expensive to test.
- Number of Devices: Service providers often offer bulk discounts for testing multiple pieces of equipment at a single location. The more devices you need tested, the lower the per-unit cost might become.
- Service Provider's Expertise and Accreditation: Companies with a proven track record, specialized accreditations, and experienced, certified technicians will typically charge more than general repair services. The rigor and scope of their quality management system also influence pricing.
- Location within Cabo Verde: While Cabo Verde is a relatively small nation, logistical challenges in reaching more remote islands or less accessible areas might add to the overall cost due to travel and accommodation expenses for the technicians.
- Frequency of Testing: While IEC 62353 mandates recurrent testing, the specific frequency may be determined by the manufacturer's recommendations, local regulations, or the risk profile of the equipment. Consistent, scheduled testing might be priced differently than ad-hoc testing.
- Scope of Work: The standard IEC 62353 test includes electrical safety tests, functional tests, and visual inspections. However, if additional performance verification or minor adjustments are requested as part of the service, this will increase the price.
- Urgency: Expedited testing services, if available, will generally come with a premium.
- Maintenance Contracts: If the testing is part of a broader maintenance or service contract with a medical equipment supplier or a dedicated third-party service provider, the cost of the recurrent testing will be bundled into the overall contract price, which can sometimes be more cost-effective.
| Equipment Category | Estimated Price Range (CVE - Cabo Verdean Escudo) | Notes |
|---|---|---|
| Basic Diagnostic/Monitoring Equipment (e.g., ECG machines, blood pressure monitors, thermometers) | 5,000 - 15,000 CVE | Standard electrical safety and basic functional checks. |
| Mid-Range Therapeutic/Diagnostic Equipment (e.g., defibrillators, basic ultrasound, patient monitors) | 10,000 - 25,000 CVE | More comprehensive safety and functional tests, may include calibration checks. |
| Complex/High-Risk Equipment (e.g., ventilators, anesthesia machines, electrosurgical units, imaging equipment) | 20,000 - 75,000+ CVE | Extensive testing, specialized calibration, detailed functional verification, potential for manufacturer-specific protocols. |
| Large Medical Systems (e.g., CT scanners, MRI scanners - may require specialized external providers) | Negotiable / Quote-Based | Highly specialized, long testing durations, often require manufacturer-certified engineers. |
Key Pricing Factors for IEC 62353 Recurrent Testing in Cabo Verde
- Type and Complexity of Medical Equipment
- Quantity of Equipment to be Tested
- Service Provider's Expertise and Accreditation
- Geographic Location within Cabo Verde
- Testing Frequency and Scheduling
- Scope of Services (basic safety vs. performance verification)
- Urgency of the Testing Request
- Inclusion in a broader Maintenance Contract
Affordable Iec 62353 Recurrent Test Service (In-service Testing) Options
Ensuring medical device safety through IEC 62353 recurrent testing (also known as in-service testing) is a critical regulatory requirement. This standard ensures that medical electrical equipment remains safe to operate after repairs or modifications, and at regular intervals. Finding affordable options for this essential service is a priority for many healthcare facilities. This guide explores value bundles and cost-saving strategies to help you manage your IEC 62353 testing budget effectively.
| Value Bundle Type | Description | Cost-Saving Strategies Included | Ideal For |
|---|---|---|---|
| Comprehensive Device Coverage Bundle | Includes testing for a large number of devices across various departments or the entire facility. | Volume discounts, streamlined scheduling, centralized reporting, dedicated account manager. | Large hospitals, multi-site clinics, organizations with a significant medical device inventory. |
| Department-Specific Focus Bundle | Tailored testing for devices within a particular department (e.g., OR, ICU, Radiology) with specific equipment types. | Optimized testing protocols for specialized equipment, reduced travel for technicians if bundled by location, priority scheduling for critical departments. | Departments with high volumes of specific medical equipment or unique testing needs. |
| Preventive Maintenance Integration Bundle | Combines IEC 62353 recurrent testing with routine preventive maintenance tasks. | Reduced scheduling conflicts, fewer site visits, potential discounts on combined services, proactive identification of issues. | Facilities looking to optimize maintenance schedules and reduce disruption. |
| Multi-Year Contract Bundle | Committing to a service provider for multiple years, often with fixed pricing. | Guaranteed pricing, budget predictability, potential for early-bird discounts, stronger supplier relationship. | Organizations seeking long-term cost stability and reliable service. |
| Digital Reporting & Asset Management Bundle | Includes robust digital reporting and integration with existing asset management systems. | Automated record-keeping, easier compliance tracking, improved asset lifecycle management, reduced administrative overhead. | Facilities aiming for digital transformation and efficient data management. |
Understanding IEC 62353 Recurrent Testing:
- Purpose: To verify the safety of medical electrical equipment during its operational life, particularly after maintenance, repair, or modification, and at specified intervals to prevent hazards.
- Key Tests: Encompasses a range of tests including protective earthing, enclosure and patient leakage currents, touch currents, and insulation resistance.
- Regulatory Importance: Compliance with IEC 62353 is often mandated by regulatory bodies and is crucial for patient safety and operational integrity.
- Frequency: Typically recommended annually or biannually, depending on the device type, risk classification, and manufacturer recommendations.
Verified Providers In Cabo Verde
Finding verified healthcare providers in Cabo Verde is crucial for ensuring quality and trustworthy medical care. When seeking the best options, understanding the credentials and accreditations of healthcare facilities and professionals is paramount. Franance Health stands out as a leading organization that rigorously vets and certifies healthcare providers, offering a clear advantage to patients looking for reliable services in Cabo Verde.
| Franance Health Certified Provider Advantage | Description | Benefit to Patients |
|---|---|---|
| Expertise Validation | Franance Health verifies the qualifications, experience, and specialized training of medical professionals. | Ensures access to highly skilled and knowledgeable doctors and specialists. |
| Patient Safety Protocols | Assessment of infection control, emergency preparedness, and overall patient safety measures. | Reduces the risk of complications and ensures a secure healthcare environment. |
| Quality of Infrastructure and Technology | Evaluation of medical equipment, facility cleanliness, and technological advancements. | Provides access to modern diagnostic and treatment tools for better outcomes. |
| Ethical Practice Compliance | Verification of adherence to ethical guidelines and patient rights. | Guarantees respectful and transparent medical treatment. |
| International Standards Alignment | Certification based on globally accepted healthcare quality benchmarks. | Offers assurance of care comparable to leading international facilities. |
Why Franance Health Credentials Matter in Cabo Verde
- Rigorous Verification Process: Franance Health employs a multi-faceted verification system that goes beyond basic licensing. They assess clinical expertise, patient safety protocols, ethical practices, and technological capabilities.
- Commitment to International Standards: Franance Health aligns its accreditation standards with internationally recognized benchmarks, ensuring that certified providers meet global best practices in healthcare delivery.
- Enhanced Patient Trust and Safety: By entrusting their healthcare needs to Franance Health-certified providers, patients gain confidence in the quality of care and the safety measures in place.
- Access to Specialized Expertise: Franance Health's network often includes specialists with advanced training and experience, making it easier for patients to find the specific medical attention they require.
- Streamlined Healthcare Navigation: Franance Health's certification acts as a trusted guide, simplifying the process of finding suitable and reputable healthcare options in Cabo Verde.
- Continuous Quality Monitoring: Certification is not a one-time event. Franance Health engages in ongoing monitoring and re-evaluation to ensure that providers maintain their high standards over time.
Scope Of Work For Iec 62353 Recurrent Test Service (In-service Testing)
This Scope of Work (SOW) outlines the requirements for conducting recurrent (in-service) testing of medical electrical equipment according to the IEC 62353 standard. This service ensures the continued safety and performance of equipment currently in use within a healthcare facility.
| Category | Description | Standard Specification (IEC 62353 Clauses) | Technical Deliverables |
|---|---|---|---|
| Test Planning and Preparation | Defining the scope of testing, identifying equipment to be tested, and scheduling activities. This includes reviewing previous test reports and equipment maintenance history. | Clause 4: Preparation for testing | Test Plan detailing equipment inventory, test schedule, and required resources. Review of historical data for identified equipment. |
| Visual Inspection | Examination of the equipment for any signs of damage, wear, or defects that could compromise safety or performance. Includes inspection of enclosures, cables, connectors, and accessories. | Clause 5.1: Visual inspection | Detailed report of visual findings, including photographic evidence of any defects. Record of any loose or damaged connections. |
| Protective Earthing (Grounding) Test | Measurement of the protective earthing conductor resistance to ensure low impedance path to earth, preventing dangerous potential build-up in case of fault. | Clause 5.2: Protective earth resistance | Measured protective earth resistance values (e.g., in Ohms). Identification of any resistance exceeding specified limits. |
| Insulation Resistance Test | Measurement of the resistance between exposed conductive parts and live parts (or earth) to ensure adequate electrical isolation and prevent electrical shock. | Clause 5.3: Insulation resistance | Measured insulation resistance values (e.g., in Megaohms). Record of test voltage applied. |
| Enclosure Leakage Current Test | Measurement of the leakage current flowing through the enclosure to earth or to accessible conductive parts during normal operation and single-fault conditions. | Clause 5.4: Enclosure leakage current | Measured enclosure leakage current values (e.g., in mA) under normal and single-fault conditions. Comparison with specified limits for applied parts and other accessible parts. |
| Patient Leakage Current Test (Type B, BF, CF) | Measurement of leakage currents flowing through the patient (or patient leads) during normal operation and single-fault conditions. | Clause 5.5: Patient leakage current | Measured patient leakage current values (e.g., in mA) under normal and single-fault conditions for respective applied parts (B, BF, CF). Verification of compliance with IEC 60601-1 limits. |
| Applied Part Leakage Current Test | Measurement of leakage currents flowing through applied parts (other than patient applied parts) to earth or accessible conductive parts. | Clause 5.6: Applied part leakage current | Measured applied part leakage current values (e.g., in mA) under normal and single-fault conditions. |
| Touch Current Test | Measurement of the current that flows through a person when touching accessible conductive parts of the equipment. | Clause 5.7: Touch current | Measured touch current values (e.g., in mA) for accessible conductive parts. |
| No-Load Output Voltage and Current Test | Verification of output voltage and current of the equipment when not connected to a load, to ensure it falls within specified parameters. | Clause 5.8: No-load output voltage and current | Measured no-load output voltage and current values. Comparison with manufacturer specifications. |
| Functional Testing | Verification of the correct operation of the equipment's primary functions to ensure it performs as intended and safely. | Clause 5.9: Functional tests | Documentation of successful functional test results for all primary functions. Record of any observed anomalies. |
| Performance Verification | Assessment of the equipment's performance against manufacturer specifications or established benchmarks. This may include accuracy, speed, and other relevant parameters. | Clause 5.10: Performance verification | Report on performance test results, including deviations from specifications. Calibration status of any test equipment used. |
| Documentation and Reporting | Compilation of all test results, findings, and recommendations into a comprehensive report, including any identified non-conformities and proposed corrective actions. | Clause 6: Documentation and reporting | Final Test Report detailing all conducted tests, measured values, compliance status, and recommendations. Unique identification of tested equipment and test dates. Certification of tested equipment (e.g., 'Passed' or 'Failed' labels). |
Key Objectives of IEC 62353 Recurrent Test Service
- Verify the continued safety of medical electrical equipment after installation and in-service use.
- Identify potential hazards or deviations from safety requirements that may have arisen during operation.
- Ensure the equipment maintains its original performance and safety characteristics.
- Provide documented evidence of compliance with IEC 62353 for regulatory and internal quality management purposes.
- Minimize risks to patients, operators, and the environment.
- Support proactive maintenance and identify equipment requiring repair or replacement.
Service Level Agreement For Iec 62353 Recurrent Test Service (In-service Testing)
This Service Level Agreement (SLA) outlines the guaranteed response times and uptime for the IEC 62353 Recurrent Test Service (In-Service Testing). This service ensures that medical devices are periodically tested to verify their electrical safety while in use, as per the IEC 62353 standard.
| Service Component | Uptime Guarantee | Response Time (Scheduled Tests) | Response Time (On-Demand Tests) | Response Time (Critical Issues) |
|---|---|---|---|---|
| Recurrent Test Service Availability | 99.5% | Within 2 business days of scheduled date | Within 4 business hours of booking confirmation | Within 2 business hours of critical issue notification |
| Technician Dispatch (Scheduled) | N/A | Within 1 business day of scheduled date | N/A | N/A |
| Technician Dispatch (On-Demand) | N/A | N/A | Within 2 business days of booking confirmation | N/A |
| Critical Issue Resolution | N/A | N/A | N/A | Target resolution within 8 business hours (dependent on complexity and part availability) |
Service Scope and Definitions
- Recurrent Test Service: Refers to the scheduled and on-demand testing of medical devices in accordance with IEC 62353.
- In-Service Testing: Testing performed while the medical device is in its normal operating environment and potentially in use by patients.
- Scheduled Tests: Tests performed at pre-defined intervals as agreed upon in the Master Service Agreement (MSA).
- On-Demand Tests: Tests requested by the client outside of scheduled intervals.
- Downtime: Any period during which the Recurrent Test Service is unavailable or significantly degraded, preventing the execution of scheduled or on-demand tests.
- Response Time: The maximum time allowed from the initiation of a support request or test booking until a technician is actively engaged in resolving the issue or commencing the test.
- Uptime Guarantee: The minimum percentage of time the Recurrent Test Service is available and operational.
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