Micralyne Achieves ISO 13485 Certification to Better Serve BioMEMS & Microfluidic Device Manufacturers

Micralyne Inc., a world-renowned, independent MEMS solutions company, has been certified to ISO 13485, reinforcing Micralyne’s position as a leading enabler for medical companies requiring advanced BioMEMS and microfluidic devices.

Edmonton, Canada, April 15, 2010 --(PR.com)-- The certification complements Micralyne’s current ISO 9001:2008 certification and makes the company one of the only MEMS solution providers with the quality assurance certification to develop and manufacture MEMS and microfluidic devices for biomedical companies.

“It is difficult for companies to find a BioMEMS or microfluidics partner that meets the biomedical device industry’s stringent regulations,” says Marvin Cervantes, Micralyne’s Quality Assurance Manager. “Micralyne’s proven knowledge and experience developing and manufacturing advanced MEMS and microfluidic components for medical device companies is now backed up with the certification to give our customers the commitment to quality that they are looking for.”

The certification means that Micralyne has met work environment requirements that ensure compliance and product safety and has proven proficient in risk management and the design transfer of medical devices. Micralyne also complies with inspection and traceability for implantable and non-implantable devices, and has proven quality processes.

Customer demand for ISO 13485 certification is on the rise. “With the MEMS-based life sciences expected to grow at 25 to 30 percent annually, companies need partners like Micralyne that can help move medically related BioMEMS products from development through to MEMS manufacturing,” says Derek Hudson, CEO of Micralyne. “We are excited to offer our medical customers this high level of assurance.”

Micralyne Inc.
Steve Jakeway