MDR
Showing 1–16 of 19 results
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CH-REP Manual for Switzerland
Conformity without a certified QMS.
2'000 CHF plus VATSelect options This product has multiple variants. The options may be chosen on the product page -

Checklist for label
for medical devices in EU and Switzerland.
175 CHF plus VATSelect options This product has multiple variants. The options may be chosen on the product page -

Contact a Notified Body
Workshop on finding and contacting a Notified Body.
200 CHF plus VATAdd to cart -

DOE Course
Learn to master design of experiments.
810 CHF plus VATAdd to cart -

EU-Konformitätserklärung (DoC)
Checkliste zur Prüfung der DoC.
50 CHF plus VATAdd to cart -

Importer Manual for Switzerland
Conformity without a certified QMS.
2'000 CHF plus VATSelect options This product has multiple variants. The options may be chosen on the product page -

Importer Training
Read moreFor Swiss Importers
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ISO 13485 Starter Kit
The QMS for your medical device.
4'150 CHF plus VATAdd to cart -

MDR Clinical Evaluation
Gap analysis tool for GCP compliance.
190 CHF plus VATAdd to cart -

MDR Review
Read moreSupport checking your SOPs against the MDR.
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MDR Risk Management
Gap analysis tool for risk management compliance.
175 CHF plus VATAdd to cart -

MDR UDI
Gap analysis tool for UDI compliance.
155 CHF plus VATAdd to cart -


MRA Solutions Finder
Tool to optimize preparation for a missing MRA.
600 CHF plus VATAdd to cart -

Post Market Surveillance
Gap analysis tool for PMS compliance.
155 CHF plus VATAdd to cart -


Process Improvement 1
Level 1. Certified Six Sigma Yellow Belt Course.
1'420 CHF plus VATAdd to cart -

RA / QA Membership
Read moreRegulatory and quality management support.









