MECAPLAST SWISS

Quality Assurance

Who says quality says compliance with the standards.
Mecaplast assure the best possible quality for your products!

Quality Assurance (QA)
and Quality Control (QC)

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 ISO 9001 and ISO 13485.

sqs
sqs
iqnet
Image

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

  • icon-addres Rte du Villard 31 – CH-1652 Botterens
  • icon-email info@mecaplast.ch
  • icon-telephone +41 26 921 84 84
  • icon-fax +41 26 921 84 81
logo-mecaplast
logo-mecaplast
Copyright © 2019 Mecaplast Swiss.
+41 26 921 84 84Rte du Villard 31 – CH-1652 Botterens