QMS
Showing all 16 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 -
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 -
ISO 13485 Starter Kit
The QMS for your medical device.
4'150 CHF plus VATAdd to cart -
ISO 9001 Starter Kit
Set up a new quality management system.
3'400 CHF plus VATAdd to cart -
IVDR Review
Read moreSupport checking your SOPs against the IVDR.
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IVDR Risk Management
Gap analysis tool for risk management compliance.
175 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 -
RA / QA Membership
Read moreRegulatory and quality management support.
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Regulatory document matrix for medical devices
For the EU and Swiss market
100 CHF plus VATAdd to cart
