At Biomedical Structures, quality is engineered into everything we do. As a highly specialized contract manufacturer of medical textiles, BMS is a purpose-built medical facility specifically designed to concentrate on our core competency so that our customers can concentrate on theirs. ISO 13485 registered, BMS has successfully passed inspections from the FDA, and brings the meticulous attention to detail required by regulatory review to the biomaterial outsourcing supply chain.
BMS holds the safeguarding of our customers’ intellectual property as our primary and most important charge, and our culture of confidentiality ensures all IP is protected from the first meeting to post-production. Customer loyalty is our top priority, and all personnel are trained to respect the ideas and methods of the medical device companies we serve. Stringent attention to information sensitivity and a strict non-competing philosophy offer customers the confidence to fully engage with our engineering team to bring unique textile solutions to devices over a variety of therapeutic indications.
Quality Assurance & Control
BMS maintains rigorous adherence to current Good Manufacturing Practices (cGMP) to avoid contamination and ensure repeatability of our products. GMP is a lifestyle that we clearly define and implement through our Quality System in order to protect the health and safety of our customers. Our fully integrated quality procedures run throughout the development process from initial product concept to volume manufacturing and packaging. And to maintain complete process control and traceability, all biomaterials are fabricated in separate clean rooms, each of which has received a certificate of performance in accordance with ISO Standard 14644-1 and meets the criteria for an ISO Class 7 environment.
Complete QA/QC services include:
- Biocompatibility assurance and testing
- Quality planning and protocol development
- Quality assurance monitoring
- Compliance and validation
- Microbiological testing
- Biomaterial testing (fibers and created structures via ASTM methods)