POLYTECH Health & Aesthetics GmbH - Quality Made in Germany Pays Off: CE Approval For Breast Implants From One of the International Leading 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.

ots Originaltext: G&G Biotechnology BV.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Information
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Karina Fritz und Margit Dellian
Hegelmaierstr. 24
74076 Heilbronn
Tel: 07131-7973760
E-Mail: k.fritz@dellian-consulting.de;
m.dellian@dellian-consulting.de
Web: www.dellian-consulting.de

Original-Content von: G&G Biotechnology BV., übermittelt durch news aktuell