Ronkonkoma, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Qosina, a global supplier of single-use components for the medical device and life sciences industries, today announced the launch of Qosina Regulatory Services. The new offering supports 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.
Brosseau will discuss the regulatory challenges that shape a medical device's path to market at MEDevice Boston, August 26-27, 2026.
For more information about Qosina Regulatory Services or to schedule a discovery call, visit https://bit.ly/Regulatory_Services.
About Qosina
Qosina is a leading global supplier of 7,000+ components to the medical and pharmaceutical industries. For more than 45 years, Qosina has helped medical device and life sciences companies accelerate product development and commercialization through an extensive component portfolio, technical expertise, quality documentation and supply-chain support. Qosina provides customers with the flexibility to source, sample and evaluate components while reducing the time and complexity involved in bringing products to market. Qosina Regulatory Services further extend that support, helping organizations navigate regulatory strategy, submissions, quality systems and compliance. For more information, visit https://bit.ly/QosinaPR.
Contact Info
Rachelle Morrow
rmorrow@qosina.com
+1 631-242-3000
