Made in Germany: Quality & Certificates

Quality you can feel in every product

Our manufacturing reflects precision, experience and a structured approach to quality and traceability across all product lines.

All POLYTECH implants and expanders are developed and manufactured in Dieburg, Germany, following controlled processes and applicable regulatory requirements.

As the medical device regulation evolves, we are progressing through the MDR transition period in line with the regulatory timelines and requirements that apply to our product portfolio.

Quality

Our products are designed and manufactured within a structured quality management system, certified according to EN ISO 13485. This system includes defined processes for development, manufacturing, and distribution of our medical devices, as required by applicable regulations.

Manufacturing & Testing

Our manufacturing processes follow defined procedures within the mandatory EN ISO 13485 and CE certified quality management systems. These include material handling, shell production, gel filling, finishing and sterilisation. All implants undergo 100% inspection at relevant stages to verify that they meet the applicable specifications. POLYTECH has set internal requirements that go beyond the quality requirements set by EN ISO 14607 on breast implants.

Implant shell production

Implant shells and each surface type — POLYsmoooth®, MESMO®, POLYtxt® or Microthane® — are produced through controlled processes that support reproducibility.

Mechanical and functional testing

Mechanical and functional tests such as elongation, tensile set, fatigue and rupture are conducted in accordance with applicable standards and with more demanding thresholds, to ensure products meet the required specifications.

Dry-heat sterilisation

POLYTECH uses dry-heat sterilisation, which does not involve ethylene oxide (EtO). Avoiding EtO reduces chemical handling and emissions and supports a safer working environment for employees working with sterilised products.^1,2

Textures & Surfaces

The MESMO® and POLYtxt® micro-textured surfaces are classified as micro-textured (SA < 50 µm) according to EN ISO 14607, based on independent measurements by the Innoproof testing institute in Rostock and other independent bodies.

Packaging & Traceability

Each implant or expander is packaged in double sterile polycarbonate blisters sealed with Tyvek® sheets.

Packaging includes:

Four adhesive traceability labels
A blank implant passport for the patient
Resource-efficient packaging, which also combines recycled paper and starch-based adhesives

In compliance with regulations, all products carry unique UDI identification, ensuring traceability from raw material to distribution.

Certificates

Certificates & Declarations

POLYTECH maintains the documentation required to demonstrate compliance with applicable regulatory and quality management requirements. This includes certificates and declarations issued by independent notified bodies and regulatory authorities.

Our documentation includes:

ISO 13485 Certificate
CE Certificate
Country-specific approvals (e.g., ANVISA, MDRC, TGA)

These certificates confirm adherence to the regulatory frameworks governing medical devices.

Report a Quality Concern

If you wish to report a concern:

Email: vigilanz[at]polytechhealth.com

Each report is handled within our post-market surveillance procedures, and you will receive a confirmation and reference number.

Commitment to Transparency

Our controlled manufacturing processes and consistent approach to compliance help ensure that every device we release is safe, traceable and supported by verifiable documentation.

Sources:

Classified as a Group 1 carcinogen by IARC
https://monographs.iarc.who.int/list-of-classifications
Listed as a Substance of Very High Concern (SVHC) under EU REACH due to carcinogenic and mutagenic properties
https://echa.europa.eu/candidate-list-table