Right the first time.
Technical Documentation for EU IVDR submission
Technical
Documentation
Technical Documentation 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 TD to help you make claims and differentiate you from other devices.
Reduce the number of deficiency findings and review rounds during your TD assessment.
Create an extension to your business and have TD creation specialists on demand. 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 EU IVDR ready?
Feeling uncertain?
why not take this quiz TO prempt your NOTIFIED BODY’s response:
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
01.
Book a 30 minute introduction call
for a rapid gap analysis.
02.
Receive a personalised project proposal
03.
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:
