Design Your QMS with Jan Meiß
Take advantage of our expertise in consulting, training, and auditing in the medical technology sector. We’re here to support you!
My services:
- Training
Professional support through customized training courses tailored specifically to your application and your company!
I specialize in:
I specialize in:
- Risk management according to ISO 14971 in the medical device industry
- Quality management systems according to ISO 13485 in the medical device industry
- Regulatory requirements under (EU) 2017/745 MDR, or
- Introduction to internal audits / supplier audits
- Auditing and Certification
I work as an experienced external auditor for several leading Notified Bodies and certification bodies. In this role, I thoroughly review your QMS and technical documentation.
Alternatively, I’m happy to assist you with mock audits, internal audits, and supplier audits.
To help you prepare as effectively as possible for internal and external audits, I’d be happy to serve as your sparring partner:
- Support with process design
- Informal feedback on your QMS
- Development of a certification strategy
- Establishment and further development of your QMS
- Consulting