Quality,
‍documented.

Yes. Maverick Biomaterials has held ISO 13485 certification from BSI since 2012, currently to ISO 13485:2016 for the manufacture of bovine and porcine serous membranes, and the scope is being extended to include collagen. Maverick also holds ISO 9001 certification.

The ISO 22442 series covers medical devices that use animal tissue. Part 1 applies risk management, Part 2 sets controls on sourcing, collection and handling, and Part 3 covers validation of the elimination or inactivation of viruses and TSE agents. Maverick works to ISO 22442-2 and supplies origin, sourcing and handling documentation. Parts 1 and 3 sit with the device manufacturer.

It applies to devices made with tissue or derivatives from bovine, ovine and caprine species, deer, elk, mink or cats, with limited exceptions such as devices that contact intact skin only. It requires a documented TSE risk analysis and Notified Body assessment. Porcine and equine material is outside the species list. Maverick supports your submission with origin and traceability documents, and regulatory advice sits with your regulatory team or Notified Body.

No, and that is expected. CE marking, FDA clearance and FDA approval apply to finished devices and medicinal products, and sit with the manufacturer. We supply starting material with the documentation that supports your submission.

Maverick’s FDA Master File is in progress. The FDA does not approve master files. It accepts them, assigns a reference number, and reviews the content when a customer’s submission references it by letter of authorisation.

Yes, for its pericardium products, and a dossier for collagen is being lodged. A CEP shows that a substance is suitably controlled by a European Pharmacopoeia monograph, and a TSE CEP addresses TSE risk for ruminant-derived materials. It does not replace a certificate of analysis for each lot.

Certificates of analysis, BSE/TSE risk statements and other supporting documents. Contact customerservice@maverickbio.com and tell us the material and what the documents are for.

Yes. We accommodate audits to support our customers’ supplier qualification, and as standard practice in an ISO 13485 controlled environment. Qualified customers can request an audit through customerservice@maverickbio.com.

Yes. Changes that could affect your material are communicated in advance, so your team can assess them before they reach production.

Chilled, frozen, freeze-dried and ambient options are available in validated shippers with temperature loggers, from -70°C to 25°C. Frozen shipments commonly use dry ice, which is regulated as dangerous goods for air freight, so packaging and airline acceptance are planned early.

We manage destination-country requirements, customs documentation and airline partners. Some countries require import permits or veterinary certificates for animal-derived material, so tell us the destination and end use when you enquire.

If material you receive does not meet your incoming inspection, let us know. We will log it in our system and investigate. Share the lot number and shipment details and retain evidence, and our Quality team will work with you towards a resolution.