Areas for Biocompatibility and Sterilization Testing and Animal Studies Advising

Biocompatibility Testing, Animal Studies, and Sterilization Testing Support Contract

CRO Support for Blueprint MedTech (BPMT) Biocompatibility, Sterilization, and Animal Studies RFP

Blueprint MedTech plans to award a contract to a contract research organization(s) to support and provide resources to participating BPMT grantees for completing biocompatibility studies, in vivo animal testing with capabilities for compliance with good laboratory practice (GLP) guidelines, and sterilization and shelf-life testing to support development of therapeutic and diagnostic neurological medical devices. This contractor will provide support for research protocol development, ensure in-house staff training, and conduct all testing necessary to support biocompatibility, sterilization, and animal safety studies, which will be used to inform regulatory filings for investigational device exemptions and marketing approval by the US Food and Drug Administration.

Areas for Biocompatibility Testing, Animal Studies, and Sterilization Testing Advising:

1: Biocompatibility, chemical characterization, extractable/leachable, and biocompatibility risk assessment
The Contractor shall provide services related to:

1. Conducting biocompatibility studies, chemical characterization studies, extractables/leachables studies, and biocompatibility risk assessment in addition to generating detailed test reports in compliance with ISO 10993 and FDA Guidance Document “Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.”
2. Maintaining all necessary licenses and certifications for compliance with PHS Policy on Humane Care and Use of Laboratory Animals.
3. Generating detailed test reports containing all relevant information from the above testing to meet regulatory requirements.
4. Providing appropriate training and maintaining records of training for all research personnel.

2: GLP-compliant animal safety studies and non-GLP studies when applicable
The Contractor shall provide services related to:

1. Completing non-GLP and GLP-compliant animal studies in small and large animal models to demonstrate safety and/or efficacy of medical devices per the needs required for regulatory assessment.
2. Maintaining all necessary licenses and certifications for compliance with PHS Policy on Humane Care and Use of Laboratory Animals.
3. Generate detailed test reports containing all relevant information from the above testing to meet regulatory requirements.
4. Providing appropriate training and maintaining records of training for all research personnel.

3: Sterilization and Shelf-Life Testing
The contractor shall provide services related to:

1. Conduct the following assessments for novel medical devices, in accordance with standards listed in the FDA Recognized Consensus Standards database when applicable:
   a. Sterilization validation testing;
   b. LAL, pyrogen, and bioburden testing;
   c. Cleaning validation and disinfection validation;
   d. Shelf-life validation testing;
   e. Packaging and transport testing;
   f. Any additional testing as listed in FDA Guidance Document “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”.   
2. Generating detailed test reports containing all relevant information from the above testing to meet regulatory requirements.
3. Providing appropriate training and maintaining records of training for all research personnel.