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Page 1: Medical Devices Regulatory Compliance services

Medical Electronics Practice

Regulatory Compliance Services

Page 2: Medical Devices Regulatory Compliance services

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21CFR Part 820, ISO 13485, CE & EU Directives Compliance

Regulatory guideline compliance – Assessment & GAP analysis

Documentation support for 510 (K) / Pre-market approval

Process, Tools Validation and Post market surveillance support

Testing- EMC/LVD/Biocompatibility (ISO 10993) & compilation of clinical data

Guidance support - Correct labeling / Instruction manual / SOP

Design & development- Risk based approach for validation (ISO 14971)

Maintaining & updating design dossier for higher risk classified devices

Maintaining of DHF/DMR- (Identification & Traceability)

CAPA support

RoHS / REACH compliance

Regulatory Compliance Support & Services

Page 3: Medical Devices Regulatory Compliance services

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Thank You

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