Listed on the MoniDoseQMS Expert NetworkNometech
Quality & Regulatory Experts | EU MDR, EU IVDR, FDA & ISO 13485
Nometech is a Quality and Regulatory partner providing hands-on expertise to medtech companies at different stages of their journey. We work with startups, scale-ups and established companies, supporting both individual Quality and Regulatory needs and longer-term assignments. Our way of working is practical and hands-on: we are not just advisors telling you what needs to be done — we work alongside your team to solve the challenges and take them through to completion. This gives you access to the expertise and knowledge behind the solution while also ensuring that the required outcome is actually achieved. Whether you need support with a single task, additional expertise for your team, or a long-term Quality and Regulatory partner, we can tailor our support to your needs.
Services offered
QMS & ISO 13485; EU MDR & IVDR; FDA; regulatory strategy & submissions; technical documentation; ISO 14971 risk management; IEC 62304 software lifecycle; AI/ML medical devices; design control & V&V; audits; CAPA & nonconformities; and Quality Manager, Regulatory Manager & PRRC services.
Regulatory scope
EU MDR, EU IVDR, FDA
Pricing
Flexible — based on scope and engagement
Responsible: Katja Koskinen (katja.koskinen@nometech.fi) · Business ID 3425316-1
The expert
Katja Koskinen
Quality & Regulatory Expert | CEO, Nometech · 15 yrs experience
Quality & Regulatory expert with extensive experience in QMS, EU MDR, FDA, ISO 13485, IEC 62304, ISO 14971, V&V and technical documentation. Through Nometech, I provide hands-on QA/RA support from individual challenges to long-term Quality Manager and PRRC assignments. My focus is on practical solutions and taking issues through to completion.
Oulu · Finnish, English
Master of Science (M.Sc.) in Electrical Engineering
Notable past roles
- CEO & Founder, Nometech — QA/RA Consultant
- Regulatory Officer & PRRC, Offcode / Lapsi Health / Testi Technologies
- COO & QMS Management Representative, Kipuwex
- Head of Validation, Nukute
- 10 years as Test Engineering Manager, Optomed