Transparent Pricing for Conformity Assessment
We are committed to transparent pricing so you can plan your budget with confidence. Because every device is different, costs are calculated case by case.
IVDR
In Vitro Diagnostic Medical Devices
QMD Services performs conformity assessments under Regulation (EU) 2017/746 via Annex IX (QMS-based assessment with technical documentation review) and Annex XI (production quality assurance).
What Affects Your Costs
Number of devices
Risk classification
Technological complexity
Risks linked to intended use
Complexity of manufacturing
Post-market surveillance requirements
Assessment Activities Over Five Years
An initial QMS audit
Four surveillance audits
At least one unannounced audit
Minimum working days per activity are set out in Table 2 of the Costs and Services Overview (1 day = 8 hours)
MDR
Medical Devices
QMD Services performs conformity assessments under Regulation (EU) 2017/745 via Annex IX and Annex XI, Part A.
What Affects Your Costs
Number of devices
Risk classification
Technological complexity
Risks linked to intended use
Complexity of manufacturing
Post-market surveillance requirements
Assessment Activities Over Five Years
An initial QMS audit
Four surveillance audits
At least one unannounced audit
Minimum working days per activity are set out in Table 2 of the Costs and Services Overview (1 day = 8 hours)
Need a Quote for Your Device?
Send us your details and we will prepare an indicative budget.
