The Single Registration Number (SRN) guarantees an EU-wide unique identification of economic actors (also outside of EUDAMED).
BEO BERLIN supports manufacturers of medical devices with regulatory requirements.
BEO BERLIN
consulting
We can efficiently support you with the conformity assessment procedure according to MDD/MDR, the application for an HMV code and implementation of a QM system.
compiling
We can handle your regulatory requirements for you, including by preparing individual documents, evalluations, complete documentation or applications.
coordinating
We can assist you with required testing and case reports to ensure your verification procedure is fully recognised, from product testing to successful test report.
Market Surveillance (PMS & PMCF) – Keeping an Eye on Changes
After signing the Declaration of Conformity the processes of market surveillance, i.e. Post Market Surveillance (PMS) and Post Market Clinical Follow Up (PMCF).
HMV Representative Keeps Track of Your HMV Codes
An HMV representative can be the key to maintaining the HMV code you have acquired and thus an essential component of the reimbursement.
MDR Goes Into 2nd Round
Finalise your switch to a technical documentation according to MDR by May 26th, 2021. Our Top 5 of important last minute adjustments.
New Standards and Standard Projects in February 2021
ISO/AWI TR7015 (Project), DIN EN ISO 1942, DIN EN ISO 17730, DIN EN ISO 10477, DIN EN 17406, ISO/IEC CD 29138-3 (Project), DIN 33411-5 (Project), DIN EN ISO 27427 (Project), ISO 17420-1, ISO 10993-12, ISO/TS 22421, ISO 10993-23, ISO/DIS 23417 (Project), ISO/CD 10993-17.2 (Project), ISO/FDIS 10993-10 (Project), ISO/CD 7176-31 (Project), ISO/DIS 7176-14 (Project)
About BEO BERLIN
BEO BERLIN advises manufacturers of medical devices on testing and approval procedures for market access.
Glossary
Your quick reference for the most important specialist terminology and keywords.
