MedtechBOSS provides advisory, set-up and maintenance for
Manufacturer:
Technical Documentation (SaMD, Technical File, Medical Device File, Design History File, Clinical Evaluation, PSUR, ISO 20417)
Quality Management System (EN/ISO 13485, US QSR, GMP, CPAKB, MDSAP, CE MDR, CE IVDR)
Distributor:
Quality Management System (GDP, GDPMD, SS620, CDAKB)
Other services:
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Conduct internal audit
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Conduct audit to critical supplier
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Support external certification/surveillance audit
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Conduct gap analysis and closure on QMS
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Conduct gap analysis and closure on Technical documentation
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Provide regulatory strategy report
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Ad Hoc Consultancy on Quality, Risk Management & Regulatory
Our team can setup document electronically or hardcopy. Refer details in our QuikQuality website.