Are you aware of medical and IVD device regulatory process?
Bringing a medical device or an IVD to market can be a nightmare of confusing regulatory standards and regulatory authority certification that must complied with and which must be integrated into the design and production of the device.
In this white paper we demonstrate in eight phases how to ensure compliance to enable medical devices to be placed on the market as smoothly as possible.
We've built this white paper by taking into account different kind of relevant standards which are also included in Innokas Standards Library, e.g.
- FDA rules and regulations
- ISO 9001:2005 and ISO 13485:2016
- Canada ISO 13485:2003 and ISO 14971
- IEC 60601, IEC 62304 and IEC 62366
Download this free white paper and you are ready to enter EU and USA market!