Safety Assurance of Your Medical Device
Biocompatibility safety
Biocompatability
Evaluations
Biocompatability testing provides safety assurance for Medical Devices. Our testing and reporting are specialised for Medical Devices.
What is the benefit?
Work with a consulting firm that is an extension of your business. We bring our experienced Toxicologists to ensure your biocompatability testing investment, in cost and time, is maximised.
Reduce the likelihood and number of deficiency findings during your CE assessment of your Device BEF. Avoid a redo of expensive and timeconsuming tests.
Create an extension to your business and have Materials and Toxicology expertise on demand to keep abreast with consumer needs and the dynamic MedTech regulations.
Are you experiencing the current problems?
If you have these problems we can help:
You don’t have the in-house resources or expertise to do an Biological Evaluation Plans to meet FDA/EU MDR.
Your previous lab created biocompatability reports and now you have deficiency findings
You are uncertain if your current Bioccompatability documents will meet the FDA or EU MDR requirements
You do not have the inhouse skills/staff/resources to do Biocompatability workflow.
Is your BIological Evaluation File (BEF) EU MDR and FDA ready?
Feeling uncertain?
why not take this quiz TO prempt your NOTIFIED BODY’s response:
Biocompatibility Evaluation (BE)
production timelines
The timeline of each medical video project differs, however, we do have averages to guide you on how long before your project is delivered.
- Materials worksheet
- BE Plan
- Chemical characterisation
- Toxicological Risk Assessment
- Laboratory testing
- BE Reports
- 1 week
- 2 - 5 weeks
- 2 weeks
- 2 - 4 weeks
- 4 - 24 weeks
- 4 - 24 weeks
Our Biocompatability Evaluations are an end-to-end service, you give us the product we do the rest:
Biocompatability plans, assessments, and evaluation reports:
- BEP
- TRA
- Chemical characterisation
- BER
Local effects
testing:
- Cytotoxicity
- Sensitisation
- Irritation
Systemic effects
Testing
- Mediated Pyrogenicy
- Toxicity
- Implantation
- Hemocompatability
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?
Here is a case study how one of our MedTech clients benefited from our Biocompatability Evaluation support. See what CLIN-r+ Toxicology team can do for your project:
Not ready to book a call?
No problem, have a look at a few of our articles on Biological Evaluation Workflow:
