Medical and diagnostic devices are special products. For projects in this sector, we offer some particular services:
Design quality according to ISO 13485
We apply the quality standard acoording to ISO 13485, both to ensure that the end result will be easier to bring to market, as well as because it is actually a useful tool in ensuring a high quality medical device development process.
Risk assessment according to ISO 14971
If our clients need assistence in doing a risk assessment according to ISO 14971, we can assist in managing the risk associated with a new product or design and documenting it appropriately.
Product development documentation
We are well aware of the requirements that medical products have to comply with in order to make it to market, and the scrutiny that the product documentation will be under. We assist our clients in compiling a complete and convincing technical file to ensure adecuate design and process documentation.
Or course depending on the product, market and sector different standards will be relevant. Some components of our standards and regulations library are:
ISO 13485:2018, ISO 1497:2019, MDR, 21 CRF part 820, EN 60601, etc….