Valicare GmbH

Qualification for Medical Device Industry

Qualification and validation ensure the quality of medical devices

Qualified equipment and validated manufacturing processes ensure reproducible high quality of medical devices.

Medical device manufacturers must ensure that their medical devices meet high quality standards to satisfy regulatory requirements and protect patients. It is therefore advisable to comply with these already during development and to consider them in all further process and manufacturing steps.

 After successful design verification and design validation, during which we can advise and accompany you, the manufacturing of the medical device is the next hurdle to overcome. The manufacturer has to ensure that the quality of the product is reproducible.

To ensure this, it is necessary to comply with the valid regulatory requirements of Din EN ISO 13485, MDR 2017/745, IMDRF and FDA, which require the validation of the associated processes in addition to the qualification of the manufacturing facilities and quality control equipment.