Regulations, Standards & Common Specifications

Providing the expertise to identify the specific and relevant Regulation(s), Common Specifications and Standards, (e.g. UK Designated, EU Harmonised, US Recognised), applicable to device(s) and country for which clearance is required. Such regulations and standards may be part of the Design Inputs (see Design Control + Risk Management), Materials selection / Bio-compatibility,  Testing, Verification & Validation, Packaging, Labelling, Clinical Evaluation, Post Market Surveillance, Distribution, Vigilance & Reporting embracing as appropriate, country specific regulations and standards.

Medical Device Regulations including countries in:

  • Europe, (EU + UK)

  • North America

  • South America

  • Asia

  • Australia

Standards Such As:

  • IEC

  • ISO

  • ANSI

  • AAMI

  • UK Designated Standards

  • EN (EC Harmonised)

  • US FDA Recognized Consensus Standards and other country specific standards e.g. Brazil INMETRO Certification

Providing cost effective support and advices to each client to obtain, collate the data to evidence compliance to defined regulations, common specifications, technical specifications and / or standards at each stage of the Life-Cycle to enable and facilitate regulatory clearance.

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