Qosina Launches Regulatory Services

Qosina, a global supplier of single-use components for the medical device and life sciences industries, has launched Qosina Regulatory Services, a new offering designed to support customers from early pathway planning through submissions and ongoing compliance.

Led by Bryan Brosseau, Qosina’s Regulatory and Quality Strategist, the new services address the regulatory and quality requirements that follow a product from development through market. From startups mapping their first regulatory pathway to established manufacturers working through complex compliance challenges, Qosina provides experience-driven guidance tailored to each organization’s needs.

“The regulatory issues that cost our customers the most time aren’t the ones they saw coming,” said Lee Pochter, CEO of Qosina. “A supplier change or a material substitution that seemed routine during development turns into a documentation problem much further down the road. Regulatory Services exist to catch that at the front end, so customers can make sourcing decisions with the right information in hand.”

Qosina Regulatory Services span quality systems, including QMS audits and gap analyses, audit preparation and remediation, and eQMS support. Submission work covers regulatory pathway planning, FDA and international submissions, CE-marking support and UDI implementation. Technical support includes design controls, risk documentation, biocompatibility, design verification and validation, supplier management and auditing, and training.

More Qosina News

Earlier this year, Qosina released its New Product Review, a brochure featuring a snapshot of the company’s continuously expanding portfolio of components.