2008-09-24 23:45:01 -
- Solutions Engineering, LLC, a leading medical device engineering, development and manufacturing firm, today announced that it has obtained ISO-13485:2003 certification.
Solutions Engineering is a medical device engineering firm dedicated to assisting medical device manufacturers with the efficient and cost-effective development of safe, high-quality products. "By obtaining ISO-13485 certification, we are not only providing our customers with a product
development platform that is important to the production of world-class medical devices," said Paul Maloney, President, "but we are also providing the benefit of an efficiently applied quality system that can save our clients' money."
Compliance with ISO-13485 is a necessary step for medical device manufacturers in achieving compliance with European regulatory requirements and an important first-step to obtaining CE marking for medical products marketed in the European Union.
"Solutions Engineering was one of the first Minnesota-based engineering and product development companies to become compliant with ISO 9001; the preceding international quality standard for world-class organizations," said Maloney. "As an ISO 13485:2003 certified design firm, we are continuing our tradition of leadership in providing our medical device customers a great benefit in terms of maintaining compliance with medical device regulations necessary to sell products in a world market."
Since its inception in 1994, Solutions Engineering has a proven track-record of helping companies worldwide take products from concept to successful commercially released products in the areas of blood pressure, specialized ECG, iontophoretics, laser Doppler, gene therapy, and blood gas analysis. Solutions Engineering is dedicated to being a leader in serving clients with integrity and ingenuity in identifying cost-effective medical device solutions.
For more information on Solutions Engineering, visit our website at: www.solutions-eng.com.
Solutions Engineering
Paul Maloney, 651-773-5224
President
