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Introduction to Medical Devices Regulation:
Ø Explanation of the regulatory framework MDR (“The way to CE mark”, EU
Ø Authorized Representative, UK RP)
Ø Overview of different regulatory bodies (e.g. EU MDR in Europe, MHRA in UK)
Ø General structure for Technical documentation according to MDR
Ø Clinical Evaluation Process for medical devices (Clinical data, Equivalence, Literature Research)
Ø Explanation of device classification systems (e.g., Class I, IIa, IIb, III in Europe & UK).
Ø Factors influencing classification (e.g., intended use, risk to the patient).
Ø Biocompatibility for medical devices
Regulatory Compliance :Challenges and Case Studies:
Ø Common challenges in achieving regulatory compliance.
Ø Overview of consultancy services, training programs, and regulatory agencies.
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