POLYTECH Health & Aesthetics GmbH – Quality Made in Germany PaysOff: CE Approval For Breast Implants From One of the InternationalLeading Companies Currently Confirmed

Dieburg, Germany (ots/PRNewswire) – On December 18, 2018, POLYTECH
sold the three millionth implant since its establishment in 1986. The
company is the only German manufacturer and present in over 75
countries worldwide. All implants are manufactured in the company’s
own production facilities in Dieburg near Frankfurt. As part of the
recertification, the company was granted the CE Mark for POLYTECH and
B-Lite® breast implants for another five years in November 2018.

Breast implants have been class III medical devices in Europe since
2003, making them one of the most closely monitored medical devices
ever (like pacemakers, heart valves and neuro implants). „As the only
German manufacturer with over 30 years of market experience, we are
one of the leading international companies in the field of
development and production of silicone breast implants. The quality
of our products and patient safety always have top priority, and we
are fully aware of our responsibility at this point,“ said Wolfgang
Steimel, CEO of POLYTECH, who has got more than 25 years of
professional experience in this area. The directors responsible for
production and registration are also experienced professionals in
this sector. POLYTECH currently offers the world’s largest product
portfolio of breast implants, available with four different surfaces
(smooth, textured in two versions and with a special
polyurethane-foam coating). Since July 2018, the innovative
lightweight implants B-Lite® have been part of the company’s
portfolio.

Pioneer in terms of quality

As early as 1995, the company was one of the first manufacturers in
the world to receive CE marking for its products and already followed
quality standards for Class III products at this early stage. With
the adoption of the new European Medical Device Regulation (MDR) in
May 2017, which must be fully implemented by May 2020, the conditions
for the registration of products have already become significantly
more stringent. All Notified Bodies must now recertify for the MDR
and demonstrate that they meet the stricter requirements. Since 2014,
the annual audits have been supplemented by regular unannounced
audits.

Risk minimization in terms of patient safety

„We have been working with a Notified Body specialising exclusively
in medical devices since the introduction of the European Medical
Devices Directive in 1994, which was the precursor to the new MDR. In
addition, we carry out extensive safety tests with test criteria that
significantly exceed the specified requirements of the relevant
standards. In addition to the permanent, in-process quality controls
of the manufactured implants, randomly selected products are
subjected to daily tests and stress tests under extreme conditions.
In addition, as part of the CE recertification, a biological
assessment/analysis was performed by an independent specialist
institute. Biocompatibility and toxicity testing of the implants also
ensure their safety. This is how we live up to our quality standards
and have been guaranteeing consistently high quality for over 30
years, thus ensuring safety for the physicians and patients who use
and trust our products,“ explains the CEO Wolfgang Steimel.

More about POLYTECH:

POLYTECH Health & Aesthetics GmbH was founded in 1986 in Dieburg and
today is one of the world’s leading companies in the field of
development and production of silicone implants. The focus is on
breast implants, which are used in reconstructive surgery as well as
in aesthetic plastic surgery. POLYTECH Health & Aesthetics is the
only German manufacturer of soft tissue implants. All products are
developed exclusively at the company site in Dieburg, Hesse and
manufactured under cleanroom conditions. The company now employs more
than 250 people and is active in more than 75 countries worldwide.
http://www.polytechhealth.com.

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Contact:
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E-Mail: k.fritz@dellian-consulting.de;
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Web: www.dellian-consulting.de

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