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 is one of the world's largest independent developers and manufacturers of microfluidics and MEMS products. Headquartered in Edmonton, Alberta, Canada, Micralyne services a diverse customer base including innovative Fortune 100 companies and high-tech start-ups. With a proven manufacturing track record and a rich development history dating back to 1982, Micralyne has helped pioneer the MEMS industry by creating some of the world's smallest mechanical structures for leading high-tech corporations.