Mitigate Risk
Your Partner for Global Compliance
At Foster, we recognize that the success of your medical device relies not just on material performance, but on your ability to guarantee patient safety and predictable market entry. We combine technical expertise with a proactive approach to regulatory support and biocompatibility testing. This comprehensive stewardship minimizes your risk, simplifies complex submissions, and helps your innovation move from concept to patient with speed and compliance.
.svg)
Comprehensive Regulatory Support for Faster, Compliant, Market Entry
Foster’s Regulatory Department is dedicated to assisting medical device manufacturers by managing the complex documentation and reporting practices for all products and transactions we coordinate. Our primary goal is simple: provide timely support that expedites your compliance, testing, and submission process for faster and compliant market entry.
Our team provides supporting documents for FDA and other global submissions. This coverage includes crucial areas like Safety Data Sheets (SDS), REACH, RoHS, Conflict Minerals, Latex, BPA, Phthalates, Animal Origin, and FDA 21 CFR compliance.
This support extends across the product lifecycle. Our pre-market documentation assists in material selection to streamline the design and initial regulatory submission. We also provide necessary post-market compliance documentation to support worldwide marketing and distribution of your medical devices.
Commitment to Quality and Regulatory Stewardship
Foster is dedicated to manufacturing and delivering high quality products, maintaining adherence to industry regulations including ISO 13485, FDA, USP Class VI, and cGMP. Foster actively manages product stewardship from its manufacturing and warehouse locations to the customer. We help to ensure that every product and transaction is supported by the proper regulatory reports and documentation. Our team is available to assist customers directly with regulatory compliance, materials testing, and supporting documentation required for FDA submissions.
Download Regulatory Documents
Minimize Risk with Foster's Biocompatibility-Tested Materials
Material biocompatibility testing, a process for evaluating how medical device materials interact with biological systems, is essential for patient safety, regulatory compliance (ISO 10993), and risk management. Foster, is committed to high-quality standards, including adhering to ISO 13485 manufacturing processes for medical devices and prioritizing formulation constituent quality. While Foster does not perform biocompatibility testing on finished compounds, we work with suppliers to prioritize use of biotested raw materials when possible, to ensure high-quality compounded formulations.
This commitment to pre-tested material significantly benefits you by lowering the risk of device qualification and helping to speed up your time-to-market. By choosing a Foster material that has already undergone USP Class or ISO 10993 testing, or one with an FDA Device Masterfile, you gain confidence and efficiency, knowing the material has already proven its safe interaction with biological systems. This proactive approach saves you time and resources during the critical regulatory submission phase.