Documentation done Right the first time.
Technical Documentation for IVDR submission
Technical
Documentation
IVD Technical Document that assures your CE mark for on-time market entry.
What is the benefit?
Work with a consulting firm that is an extension of your business. We help transfer your current product documents to create a Technical File to help you submit to regulators, make claims and differentiate you from other devices.
Reduce the number of deficiency findings and review rounds during your EU IVDR assessment.
Create an extension to your business and have Technical Document creation specialists on demand when you need it. Optimise your current TD to minimise future maintenance.
Need support?
If you have these problems we can help:
You don’t have the in-house resources or expertise to do EU IVDR 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 IVDR 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.
IVD Technical Documentation
production timelines
The timeline of each IVD TD project differs. However, we have made assumptions based on all validations being present a 60% gap to guide you on how long a project will take to be delivered.
- Gap Assessment
- IVDD to IVDR update
- 510k to IVDR translation
- New MD
- Remediation
- 1 week
- 8 - 18 weeks
- 12 - 18 weeks
- 12 - 52 weeks
- 4 - 24 weeks
IVD Technical Documentation
production costs
It is hard to provide an accurate answer for this as there are many factors that play into IVD 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
- IVDD to IVDR update
- 510K to IVDR 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+ insight:
01.
Book a 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 resource on how to structure your IVD Technical Documentations or contact us for case studies on how one of our MedTech clients benefited from our IVD TD support and what we can do for you:
Not ready to book a call?
No problem, have a look at a few of our articles on IVD Technical Documentation Workflow:
