IT & meer has over 10 years of experience with Quality Assurance in clinical research and in the medical device sector. Besides conducting audits, I can also help your company with the following:
- Consultancy on a broad range of QA topics
- Prepare for FDA / EMA / Notified Body audits / inspections
- CAPA processing
- GAP analysis
- Deal with non-conformities after an audit or inspection
- GDPR compliance
- Temporary support for your QA department
Do you need something else? Feel free to contact me..
A complete overview of regulations and standards that IT & meer has experience with please have a look at the About page. You can also find our sector experience there.