MyoPowers heeft ISO certificaat ontvangen
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MyoPowers Medical Technologies SA (www.myopowers.com) maakt vandaag bekend een certificering van de Organization for Standardization (ISO) te hebben ontvangen, te weten ISO 13485:2003 voor het “ontwerp, de ontwikkeling, productie, fabricage en de distributie van actieve implanteerbare medische hulpmiddelen ter behandeling van incontinentie.” Het bedrijf is op dit moment een kunstmatige sluitspier aan het ontwikkelen voor de behandeling van ernstige incontinentie van de urinewegen bij zowel mannen alsook vrouwen. MyoPowers Medical Technologies is een Zwitsers beginnend bedrijf dat kunstmatige spieren ontwikkeld en bouwt ter behandeling van de disfunctie van de sluitspier en incontinentie.
Engelstalig bericht:
Swiss Medtech Startup, MyoPowers, Receives ISO 13485:2003 Quality Management System Certification and Positive Statement on Clinical Investigation Plan from Notified Body
Validation Underscores Medical Device Startup’s Commitment to Quality Performance
LAUSANNE, Switzerland–(BUSINESS WIRE)– 20110308 —
MyoPowers Medical Technologies SA (www.myopowers.com), a Swiss medical device startup company which develops and manufactures artificial muscles to treat sphincter dysfunction and incontinences, announced today that it has received the International Organization for Standardization (ISO) 13485:2003 certificate for the “design, development, production, manufacture and distribution of active implantable medical devices for the treatment of incontinence.” The company is currently developing an artificial urinary sphincter to treat severe urinary incontinence in both males and females.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
“Receiving the ISO 13485 certification bears testimony to the company’s ability and commitment to provide patients with safe, high quality products, starting right from the product design and development stage. We are very proud of this achievement as it’s a major milestone for any company but especially for a startup company,†stated Martin Horst, CEO of MyoPowers.
MyoPowers’ quality review was performed by TÜV SÜD (www.tuev-sued.de), an international certification organization, based in Munich, Germany.
Clinical Investigation Plan
MyoPowers submitted the clinical investigation plan for the clinical study for male patients to TÃœV SÃœD and received a positive statement from the clinical reviewer on the three month patient follow-up period and number of patients for the study.
Urinary incontinence affects more than 200 million people in the developed world. Artificial urinary sphincters are used to treat severe urinary incontinence arising from radical prostatectomy and benign prostatic hyperplasia in men, and intrinsic sphincter deficiency in women. 85% of the urinary incontinence population are women.
About MyoPowers:
MyoPowers Medical Technologies, formerly known as Nanopowers, was founded by Dr Piergiorgio Tozzi of the University Hospital of Lausanne (CHUV) and Professor Daniel Hayoz of the Cantonal Hospital of Fribourg and the CHUV. In 2009, the company was selected as one of the best innovative medical technology companies by the Swiss Commission for Technology and Innovation (CTI) and won third prize for best abstract at the European Association of Urology congress in Barcelona in 2010. MyoPowers is funded by Novartis Venture Fund (www.venturefund.novartis.com), Gran Plasa and Initiative Capital Romandie (www.defigestion.ch).
