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.
Posted April 14th, 2010