MECAPLAST SWISS
Quality Assurance
Who says quality says compliance with the standards.
Mecaplast assure the best possible quality for your products!
Quality
Together with customer satisfaction, quality is the most important aspect at MECAPLAST. A Quality Management System is implemented, ensuring, at any time, product quality and safety.
Quality Control
Quality control is implemented at every critical step of the manufacturing and production process. Process capability is regularly used for measuring variability of output processes. Our laboratory is fully equipped and, therefore, your product can be tested in order to guarantee the conformity within your specifications.
Certification
MECAPLAST is certified to ISO13485:2016.
Regulatory affairs
MECAPLAST can support you in Regulatory Affairs ensuring that your product meets and complies with the norms and standard requirements.
Product registration file
MECAPLAST can draw up a complete technical file for the CE registration of your product.
Legal Manufacturer
MECAPLAST can take the role of legal manufacturer, whilst your company keeps full intellectual and commercialisation rights to your product.
Regulatory affairs
MECAPLAST can support you in Regulatory Affairs ensuring that your product meets and complies with the norms and standard requirements.
Product registration file
MECAPLAST can draw up a complete technical file for the CE registration of your product.
Legal Manufacturer
MECAPLAST can take the role of legal manufacturer, whilst your company keeps full intellectual and commercialisation rights to your product.
Sterilisation
Depending on the properties of your product, such as raw material, design and functionality, the proper method of sterilisation is selected. Thanks to our partners, we take care of the whole sterilisation process: Ethylene Oxide (ETO), gamma, e-beam, x-ray, steam.
VALIDATION
Mecaplast can make the validation
full report IQ, OQ, and PQ.
MICROBIOLOGY
Mecaplast is able to take care of the complete sterilisation and submit a full report. Bioburden, sterility tests, pyrogen test (LAL) and EO residues are common microbiology tests that Mecaplast can outsource and coordinate with our partner laboratories.
MECAPLAST SA
Rte du Villard 31 – CH-1652 Botterens
info@mecaplast.ch
+41 26 921 84 84
+41 26 921 84 81
