CE Marking certification service for medical devices ensuring compliance with European regulatory requirements and quality standards. BSI provides conformity assessment, notified body services, and guidance on global certification pathways to enable safe device market placement.
Manufactured by
BSI Group Ltd.
Milton Keynes, United Kingdom
We guide you on your journey to meet global standards, promote safety, and enhance trust with your clients. As the world's first national standards body, our unrivalled global expertise and long-standing commitment to public benefit and innovation sets the benchmark for regulatory excellence. Our comprehensive portfolio offers you a wide range of proven regulatory and quality management services to support you in bringing compliant devices to market efficiently and safely. CE certification UKCA Certification ISO 13485 certification MDSAP Certification – Medical Device Single Audit Program and many more specialized solutions tailored to your regulatory needs.
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Certiquality srl · Italy
CE marking certification and regulatory compliance service for medical devices. Supports manufacturers in obtaining CE marks through assessment of supply chain qualification, legal compliance monitoring, and process control documentation. Ensures devices meet EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.
Passarini Group · Brazil
Regulatory consulting service specializing in CE marking and global medical device compliance. Assists manufacturers with quality system updates, regulatory registration, and certification processes across multiple jurisdictions including Brazil, FDA, and European markets.
Maven Profcon Services LLP · India
Regulatory consulting services supporting medical device manufacturers through EU MDR conformity assessment, technical documentation preparation, clinical evaluation, risk management, and mock audits for CE certification.
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