Right the first time and onward.
Compliant plans (CEP) and Reports (CER)
Clinical Evaluation
CER's that Balance regulatory, business risks and Commercial objectives
What is the benefit?
Work with a consulting firm that is an extension of your business. We help create CER’s to help you make claims, obtain clearance (CE) and differentiate you from other devices.
Reduce the number of deficiency findings during your CE assessment. Meet your EU launch deadline.
Create an extension to your business and have Clinical Affairs on demand. Optimise your current CER so that it is easy to update and has a compliant flow to ensure audit readiness every time.
Need support on Clinical Evaluations?
If you have these problems we can help:
You don’t have the in-house resources or expertise to do an EU MDR CER
Your previous MDD/MDR CER has deficiency findings and need urgent remediation
You are uncertain if your current CER draft will meet the EU MDR requirements
You need to translate your MDD CER to be MDR compliant
Is your Clinical Evaluation 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.
Clinical Evaluation
production timelines
The timeline of each CER
project differs. However, we have averages to guide you on how long a project will take to be delivered.
- Update
- Investigation Data route
- SoTA only
- Equival/benchmark route
- WET and SoTA route
- 2 - 4 weeks
- 2 - 5 weeks
- 2 - 5 weeks
- 6 - 8 weeks
- 6 - 12 weeks
Clinical Evaluation
production costs
It is hard to provide an accurate answer for this as there are many factors that play into CER production, so it depends on the gap assessment.
We have provided average costs as a guide but book a call with our team to confirm the exact costs for your project.
- Update
- Investigation Data route
- SoTA only
- Equival/benchmark route
- WET and SoTA route
- £1,500 - £5,500
- £2,500 - £7,000
- £5,500 - £12,500
- £7,500 – £22,600
- £12,000 - £32,000
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 our case study on how we have helped other MedTech manufacturers 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 Clinical Evaluation Workflow:
