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Consulting Services for Testing Medical Devices (Guidelines from MDR 2017 & CDSCO)
Navigating the Regulatory Landscape for Medical Devices in India
In India, the Medical Devices Rules, 2017 (MDR 2017), administered by the Central Drugs Standard Control Organization (CDSCO), provide a comprehensive and continuously evolving regulatory framework aimed at ensuring the safety, quality, and effectiveness of medical devices. For manufacturers, importers, and distributors, adhering to these regulations, particularly regarding product testing, is not just a procedural requirement but a critical factor for market access and safeguarding patient health.
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At Accredium Certifications, we comprehend the intricate details of MDR 2017 and the guidelines set by CDSCO. Our consulting services specialized in medical device testing are carefully crafted to assist you at every stage of the testing and approval journey, guaranteeing that your devices comply with India's rigorous regulatory standards.
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What We
Offer
Our All-Inclusive Medical Device Testing Consulting Services
Accredium provides a comprehensive consulting solution, collaborating with you from the initial evaluation to the successful CDSCO approval process for testing.
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Our offerings encompass:
1. Development of Device Classification & Testing Strategy:
Risk Classification Evaluation: Accurately assess the classification of your medical device (Class A, B, C, or D) according to MDR 2017.
Identification of Relevant Standards: Determine the specific national (BIS) and international (ISO, IEC) standards related to your device's safety and performance, as stipulated by CDSCO.
Customized Testing Plan: Create a detailed testing strategy outlining the necessary tests (such as biocompatibility, electrical safety, performance, sterility, shelf-life, clinical evaluation, etc.) and their respective methodologies.
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2. Selection & Coordination of Laboratories:
Guidance on CDSCO-Registered MDTL: Assist in identifying and coordinating with CDSCO-registered Medical Device Testing Laboratories (MDTLs) or NABL-accredited labs qualified to conduct the required tests for your specific device class.
Protocol Review for Testing: Assess and validate testing protocols to ensure they comply with MDR 2017 and related standards, thus preventing future non-conformance.
Advice on Sample Management: Offer guidance on proper methods for sample preparation and submission to testing labs.
3. Compilation of Documentation & Reports:
Support with Device Master File (DMF): Help in the creation of the Device Master File (DMF) and Plant Master File (PMF) components relevant to design verification, validation, and testing.
Thorough Review & Interpretation of Test Reports: Carefully evaluate test reports issued by laboratories, ensuring they are complete, accurate, and conform to CDSCO submission standards.
Assistance with Essential Principles Checklist (EPC): Support in demonstrating adherence to the Essential Principles of Safety and Performance through the necessary checklist, reinforced by solid test data.
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4. Support for Regulatory Submission After Testing:
Guidance for Form MD-40 Submission: Offer professional assistance in the preparation and submission of Form MD-40 (Application for testing or evaluation of a medical device by a manufacturer) along with other pertinent forms through the SUGAM portal online.
Addressing Inquiries: Aid in responding to any questions or clarifications that CDSCO may have during the assessment of your testing documentation and application.
Ongoing Compliance Guidance: Advice on post-market surveillance (PMS) obligations and periodic safety update reports (PSURs) concerning the continuous performance and safety of the device.
Reasons to Choose Accredium Certifications:
Extensive Regulatory Knowledge: Our team has comprehensive expertise in the Indian Medical Devices Rules, 2017, as well as the most recent guidelines and amendments from CDSCO.
Collaborative Partnerships: We collaborate closely with a network of NABL-accredited and CDSCO-registered testing laboratories throughout India, ensuring effective and dependable testing.
Customized Solutions: We recognize that each medical device is distinct. Our services are tailored to your particular device, its risk classification, and your business requirements.
Speed and Efficiency: Our aim is to optimize your testing and regulatory approval process, reducing delays and hastening your market introduction.
Consistent Support: From the initial consultation to the final approval, we provide committed assistance, simplifying a complex process for you.
Make sure your medical devices comply with India's rigorous safety and performance regulations. Collaborate with Accredium Certifications for expert advice on Medical Device Testing in accordance with MDR 2017 and CDSCO Guidelines.
Reach out to us today for a consultation regarding your medical device testing and regulatory requirements.
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The Importance of Professional Assistance in Medical Device Testing
The MDR 2017 categorizes medical devices into four risk-based classes (Class A, B, C, D), each with distinct testing and documentation requirements. The necessary testing spectrum can be extensive and complicated, covering areas such as biocompatibility, electrical safety, performance validation, and sterilization efficacy.
Navigating these requirements independently without professional guidance may result in:
Delays in Market Access: Errors in testing procedures or incomplete documentation can lead to denials and considerable time setbacks.
Heightened Expenses: Oversight in compliance may necessitate extra testing or re-testing, which can be costly.
Regulatory Non-Compliance: This can lead to fines, product recalls, or even the removal of products from the market.
Hazardous Patient Safety: Insufficient testing might result in unsafe devices reaching consumers.
Accredium Certifications delivers the expertise and insights required to achieve efficient and compliant medical device testing.
4. Support for Regulatory Submission After Testing:
Guidance for Form MD-40 Submission: Offer professional assistance in the preparation and submission of Form MD-40 (Application for testing or evaluation of a medical device by a manufacturer) along with other pertinent forms through the SUGAM portal online.
Addressing Inquiries: Aid in responding to any questions or clarifications that CDSCO may have during the assessment of your testing documentation and application.
Ongoing Compliance Guidance: Advice on post-market surveillance (PMS) obligations and periodic safety update reports (PSURs) concerning the continuous performance and safety of the device.
Reasons to Choose Accredium Certifications:
Extensive Regulatory Knowledge: Our team has comprehensive expertise in the Indian Medical Devices Rules, 2017, as well as the most recent guidelines and amendments from CDSCO.
Collaborative Partnerships: We collaborate closely with a network of NABL-accredited and CDSCO-registered testing laboratories throughout India, ensuring effective and dependable testing.
Customized Solutions: We recognize that each medical device is distinct. Our services are tailored to your particular device, its risk classification, and your business requirements.
Speed and Efficiency: Our aim is to optimize your testing and regulatory approval process, reducing delays and hastening your market introduction.
Consistent Support: From the initial consultation to the final approval, we provide committed assistance, simplifying a complex process for you.
Make sure your medical devices comply with India's rigorous safety and performance regulations. Collaborate with Accredium Certifications for expert advice on Medical Device Testing in accordance with MDR 2017 and CDSCO Guidelines.
Reach out to us today for a consultation regarding your medical device testing and regulatory requirements.