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.