Right the first time and onward.
Clinical Evaluation Plans and Reports
Clinical
Evaluations
Clinical Evaluations that balance regulatory, clinical and business risks and objectives
What is the benefit?
Reduce the number of deficiency findings during your CE assessment.
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 agency created a MDD/MDR CER and now you have deficiency findings
You are uncertain if your current CER draft will meet the EU MDR requirements
You are uncertain if your current CER draft will meet the EU MDR requirements
Is your Clinical Evaluation workflow EU MDR ready?
unsure?
why not take this quiz TO pre-Assess the NB response
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
01.
Book a 30 minute introduction call
for a rapid gap analysis.
02.
Receive a personalised proposal
03.
Spend time 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:
