Quality
Quality requires a consistently high quality standard, a good basis for evaluating which is provided by purity and maximum uniformity of particle size.
Naturelize products are manufactured in accordance with international standard ISO 13485 and EU Directive 93/42/EEC.
The raw material for manufacturing naturelize hyaluronic acid products is obtained through a fermentation process. All naturelize hyaluronic acid products are therefore of non-animal origin.
Products are not filled and packaged for further use until all required quality guarantees are present.
Person Responsible for Regulatory Compliance (PRRC) according Article 15 of MDR 2017/745 (EU) Phone: +49 (0) 171 695 43 17
Products:
Hyaluronic acid is safe to use and, as a nature-identical product, does not generally cause allergic reactions.
##Innovation:
Naturelize hyaluronic acid products are at the cutting edge of thixotropic technology. To date, naturelize products are the only products of this type to make use of this technology, which makes application easier and much more controllable.
##Thixotropic technology:
Modified flow behavior under the pressure generated by the piston of the syringe, i.e. this technology causes the gel to become more liquid during the injection process before regaining its viscosity once in the tissues. This ensures better persistence at the augmentation site. Product quality: to enable practitioners to achieve as precise and predictable a result as possible, naturelize products have been developed to exert an optimized effect and to be able to be reproducibly manufactured to an optimum product quality. Usage information and best practice guidelines are available to download for each product.
The quality standard for the purity of our products is specified in the European Pharmacopoeia. Naturally our products meet the strict criteria given in this specification.
Primary benefits of using naturelize products:
- reproducible volume augmentation effect
- length of time for which the product remains in the tissues can be reliably calculated
- extended period before volume begins to reduce
- high product purity helps prevent complications
- highest product quality for optimum tissue compatibility
Safety
Naturelize products are subjected to all essential, prescribed product tests required for safe use of the products. This encompasses in particular tests for sterility, endotoxins and pyrogens.
Only after all tests have been performed to our complete satisfaction are the products released for further processing. This eliminates any risk of contamination from the manufacturing process.