Documentation Right the first time
Technical Documentation for EU MDR submission
Technical
Documentation
Medical Device Technical Document that assures a CE mark for on-time market entry.
What is the benefit?
Work with a consulting firm that effectively expands your business expertise. CLIN-r+ consultants help transfer your documentation to help you make claims and differentiate you from other devices.
Reduce the number of deficiency findings and file review rounds during your EU MDR TD assessment.
Create an extension to your business and have TD creation specialists on demand. Optimise your current dossier to minimise future maintenance and NB audit findings.
Need support?
If you have these problems we can help:
You don’t have the in-house resources or expertise to do EU MDR TD. Or perhaps you have a tight deadline.
Your device has FDA clearance and now you need to translate that to European CE.
You are uncertain if your current TD draft will meet the EU MDR requirements.
Your TD has already had deficiency findings in one or more of your total 3 reviews with your notified body.
Is your Technical Documentation workflow EU MDR ready?
Unsure?
Why not book a free 15 min assessment with an experienced consultant to pre-assess your auditors (NB) response. You will receive a personalised score card to guide your corrective action plan.
MDR Technical Documentation
production timelines
The timeline of each MDR TD project differs. However, based on all validations being present and a 60% gap, these timelines are guidance on how long a project will take to be delivered.
- Gap Assessment
- MDD to MDR update
- 510k to MDR translation
- New MD
- Remediation
- 1 week
- 8 - 18 weeks
- 12 - 18 weeks
- 12 - 52 weeks
- 4 - 24 weeks
MD Technical Documentation
production costs
It is hard to provide an accurate answer for this as there are many factors that play into MDR TD production, so it depends on the gap assessment. We have provided average costs as a guide, but you can book a call with our team to confirm the exact costs for your project.
- Gap Assessment
- MDD to MDR update
- 510K to MDR translation
- New MD
- Remediation
- £3,500 - £8,500
- £18,500 - £98,000
- £21,500 - £125,000
- £32,500 - £218,600
- £21,500 - £108,500
Next steps to get CLIN-r+ support:
01.
Book a free 30 minute introduction call
for a rapid gap analysis.
02.
Receive a personalised
gap assessment and detailed project proposal.
03.
Onboard the CLIN-r+ team and spend time on daily business,
where it matters.
How can Clin-r+ help?
See this case study how none of our MedTech clients benefited from our TD support. See what CLIN-r+ can we do for your project:
Not ready to book a call?
No problem, have a look at a few of our articles on Medical DeviceTechnical Documentation Workflow for EU MDR:
