EN ISO 13485 defines international requirements for quality management systems for medical devices. Certification is more than just document review: During on-site audits, our experienced auditors assess how your quality management system is actually implemented—accurately, neutrally, and transparently.
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Advantages of Certification
Market Access
In particular, for suppliers, certification according to ISO 13485 is a prerequisite for market access.
Global recognition
Certification according to EN ISO 13485, alongside MDSAP, is recognized as a leading international quality standard in the medical device industry.
Legal Certainty
Proof of compliance with all legal requirements, thereby minimizing liability risks.
Competitive Advantage
Differentiation through proven safety and performance in a highly regulated market.
Trust
Strengthening the trust of manufacturers, users, and healthcare institutions in your products.
MDSAP and ISO 13485
In Australia, Brazil, Canada, Japan, and the USA, ISO 13485 certification is complemented by the MDSAP (Medical Device Single Audit Program), which consolidates several country-specific requirements into a single audit. We also offer combined certifications according to EN ISO 13485 and MDSAP.
Advantages of Working with Berlin Cert
Expertise
Our auditors have industry-specific expertise in the medical device sector.
Precision & Neutrality
Our auditors conduct assessments with precision and neutrality.
Confidentiality
The protection of confidential information is our top priority.
On-Site Audit
We place special emphasis on on-site audits, as they reveal how your medical device quality management system is actually implemented and where potential improvements lie.
