This is team work in its purest form: Headed by the Manager for Regulatory Affairs, during the past two months all departments were busy with the preparations. Then came April 21, the start of the audits, which ended on April 23, 2021. Already on this same day we received the notification: not a single deviation – not even a tiny comment, nothing. Not only does Human Med manufacture excellent medical devices, we have our research and development, production processes and product documentation fully under control – and this has now been officially confirmed.
– Audit according to the guideline for medical devices 93/42/EEC
Hence the use of a comprehensive quality management system in the company is an important regulatory requirement; Furthermore, our extensive design documentation (design dossier) was absolutely convincing: On the basis of the design dossier, the auditors were able to check compliance with all the necessary requirements for the production and marketing of medical products and mark them as impeccable.
– Medical Device Single Audit Program (MDSAP) audit
The MDSAP audit model ensures that the MDSAP audits are carried out uniformly worldwide by the auditing organizations and that any system-related deviations in the quality management system are also determined using uniform parameters worldwide. Successful completion of the MDSAP audit is extremely important for Human Med: With this we can continue to successfully position our product portfolio in Canada, USA and Australia.
Is that all? Of course not – the next big project is UDI (Unique Device Identification) – we have been actually in the middle of it for quite a while.
To be continued!