Welcome to TEC
provide you with over 20 years experience in the medical device,
pharmaceutical and biotechnology industry market.
developed a deep understanding in MDD / MDR, IVDD / IVDR, and 21CFR820
regulations, EN ISO 13485 and GMP- /GLP- /GVP- QMS.
External Lab Manager according to RiliBÄK / ISO15189 / GLP.
support regarding Medical Devices : IVDD / IVDR, MDD / MDR, MPG,
MPKPV, DIMDIV, 21CFR820.
We can help you as an external DPO - Data
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.
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
We support you for ... CAPA, Risk Management according ISO 14971,
complaint handling and more.