Medical Device Biological Evaluation Plan

Medical Device Biological Evaluation Plan

We conduct Biological Safety Evaluations in accordance with ISO 10993-1 to identify and assess potential biological hazards and risks related to the clinical use of your medical device.

1 Report Delivery

3 Weeks

2 ISO 10993-1

Biological evaluation of medical devices

3 FDA/MDR

Meets the requirements

4 ISO10993

Provides comprehensive testing plan

5 Completed by in-house toxicologist

Competent person

We’ve relied on Test Cert for multiple medical device testing projects, and they’ve never disappointed. Their team has deep knowledge of ISO 21530 and other relevant standards. Their timely, well-documented test reports helped us meet both local and international regulatory requirements with ease.”
– Dr. Ayesha Malik, Regulatory Affairs Manager, Meditech Solutions.

List Of Tests

Our Medical Device Biological Evaluation Plan Services provide comprehensive support for assessing biological safety and ensuring regulatory compliance. Our expert team, led by in-house toxicologists, develops customized testing plans and provides guidance on navigating complex regulatory requirements.

1 ISO 10993-1 Biological Evaluation

Assessing biological safety of medical devices, ensuring compliance with international standards for biocompatibility and risk assessment.

2 FDA/MDR Compliance

Meeting regulatory requirements for market access in the US and EU, ensuring devices meet stringent safety and efficacy standards.

3 Comprehensive Testing Plan

Developed by in-house toxicologists (competent persons), outlining necessary tests and evaluations to ensure biological safety.

4 Expert Guidance

4. Provided by experienced toxicologists and regulatory experts, helping navigate complex regulatory requirements.

Reviews

Fatima Riaz

Co-Founder, NovaMed Devices

Imran Qureshi

QA/RA Lead

Haroon Sheikh

As a startup in the medical device field, we needed guidance on compliance and validation. The experts at Test Cert walked us through the process and even helped interpret ISO 13485 requirements. Their clarity and support have been invaluable.

Test Cert Laboratory provided excellent biocompatibility and sterility testing services for our Class II medical devices. Their lab is well-equipped and their documentation is audit-ready. We felt confident submitting their results to our notified body.

Test Cert Laboratory understands how critical timelines are in medical device registration. We were impressed with their swift turnaround and regular updates. Their team maintained clear communication from sample submission to report delivery

FAQ

What types of medical devices does TestCert test?

We provide testing services for a wide range of medical devices including diagnostic equipment, therapeutic devices, implantables, in-vitro diagnostics, and more. Our services cover both electrical and non-electrical medical devices.

What testing standards do you follow?

TestCert adheres to international testing standards such as ISO 13485, IEC 60601 series, ISO 14971 for risk management, and other relevant ISO and FDA guidelines to ensure device safety, performance, and regulatory compliance.

How long does testing usually take?

Testing timelines depend on the scope and complexity of the device and tests required. On average, testing takes between 2 to 8 weeks. We provide estimated timelines during the project planning phase.

What types of tests do you offer?

We offer a comprehensive suite of tests including:

Electrical safety and performance testing
Biocompatibility testing
Mechanical and durability testing
EMC (Electromagnetic Compatibility) testing
Chemical and toxicological testing
Sterilization validation
Packaging integrity tests

Do you assist with regulatory submissions?

Yes, TestCert offers consultancy to help you prepare technical documentation and test reports suitable for submission to regulatory authorities such as the FDA, CE marking bodies, and other international agencies.