MedtechBOSS provides advisory, set-up and maintenance for

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Manufacturer:

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Technical Documentation (SaMD, Technical File, Medical Device File, Design History File, Clinical Evaluation, PSUR, ISO 20417)

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Quality Management System (EN/ISO 13485, US QSR, GMP, CPAKB, MDSAP, CE MDR, CE IVDR)

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Distributor:

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Quality Management System (GDP, GDPMD, SS620, CDAKB)

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Other services: 

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• Conduct internal audit

• Conduct audit to critical supplier

• Support external certification/surveillance audit

• Conduct gap analysis and closure on QMS

• Conduct gap analysis and closure on Technical documentation

• Provide regulatory strategy report

• Ad Hoc Consultancy on Quality, Risk Management & Regulatory

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