Biological Evaluations to ISO 10993

Overview

Understanding whether a medical device technology is biocompatible is a complex task that requires understanding the intended purpose of the device as well as the duration and type of human contact. In order to understand the biocompatibility of your device, it is important to undertake biological evaluation. This evaluation is based on the assessment of test data demonstrating the mechanism of action, chemical and physical composition (characterization data) and the results of biocompatibility tests. NSF Health Sciences provides consulting and education in the area of biological evaluation in accordance with ISO 10993 Part 1 and advises on all parts of the ISO 10993 collateral standards.

For more information about biological evaluations to ISO 10993 in the U.S., email medicaldevices@nsf.org or call +1 202.822.1850.

For more information about biological evaluations to ISO 10993 in Europe, email eudevices@nsf.org or call +44 1143 600 868.

 
Services

Pre-Clinical Biological Evaluation

We provide expert evaluation of the safety of your medical device with regard to pharmacological, chemical and physical mechanisms of action as well as toxicological evaluation of a range of medical technologies as part of pre-clinical submissions.

Biological Evaluation to ISO 10993 Part 1

We provide product risk and safety assessments in order to identify the critical characteristics of your product and advise on the necessary physical, chemical and biocompatibility testing requirements. We provide clear guidance on your biocompatibility testing program to ensure you undertake the appropriate studies within your time and budget parameters.

Regulatory Submission Technical Documentation

We provide expert reports and assessments for a range of material safety and biocompatibility issues associated with international regulatory submissions. Our professionals are internationally renowned experts in the field of biological evaluation, testing and toxicological studies of medical technologies.

Education

With a background in providing biological evaluation and safety assessment education to international regulators, we are more than equipped to educate you and your team in a variety of product safety and biocompatibility-related aspects including understanding all parts of ISO 10993. We have provided training to the U.S. FDA, European notified bodies and international delegations.

 
Why Work With NSF?

NSF maintains a commitment to outstanding service and quality. We focus on your business objectives through the use of sound science and proven expertise. Initial consultations are provided as a professional courtesy. Our expertise covers a wide range of therapeutic areas, product types and regulatory specialties.