Welcome to TEC

We provide you with over 20 years experience in the medical device, pharmaceutical and biotechnology industry market.

 We developed a deep understanding in MDD / MDR, IVDD / IVDR, and 21CFR820 regulations, EN ISO 13485 and GMP- /GLP- /GVP-  QMS.

As External Lab Manager according to RiliBÄK / ISO15189 / GLP.

Regulatory support regarding Medical Devices : IVDD / IVDR, MDD / MDR, MPG, MPKPV, DIMDIV, 21CFR820.

Quality Management
Risk Management
We can help you as an external DPO - Data Protection Officer!
We can help you and""hands-on” support during development and implementation of a QMS as well as the transition to EN ISO 13485:2016.
 It's our pleasure to consult you on your way to a regulatory-compliant manufacturing of your medical devices, in Europe.
Contact - Research Reagents  - Impressum
We provide Research Labs with well selected Research Reagents.

We can help you as an Interim Quality Manager/QA preparing design history files, device master records, and the technical documentation of your medical devices...
We support you for ... CAPA, Risk Management according ISO 14971, complaint handling and more.