Medical devices

LEGAL REQUIREMENTS

Medical directives were introduced into the Polish legal system by the Act of 20 May 2010 on medical devices and executive certificates issued on its basis. According to the Act, medical devices must be designed and manufactured in such a way that their use does not jeopardize the health and safety of patients. The products must meet the appropriate microbiological purity criteria.

WHAT ARE MEDICAL PRODUCTS AND WHY SHOULD YOU TEST IT?

Medical devices are:

  • materials for dressings, diagnostic tools and instruments
  • products with a significantly limited mechanism of action in comparison to a medicinal product, e.g. ointments, capsules, lozenges

It is necessary to ensure a low level of microbiological contamination in medical devices, because the presence of microorganisms in the product may adversely affect the health of patients.

OUR CERTIFICATES AND PERMITS

The Mikrolab company is authorized by the Main Pharmaceutical Inspector to manufacture (study) medicinal products and investigational medicinal products (for clinical trials) in the field of microbiological quality control of non-sterile products.

Mikrolab has a GMP certificate approved by the Main Pharmaceutical Inspector.

WHAT TESTS WE OFFER

  1. Microbiological analysis of medical devices when releasing a series
  2. Microbiological analyzes of raw materials used in their production
  3. Test on microbiological stability during storage
  4. Determination of the microbial population on products to be sterilized to determine the initial microbiological contamination to establish effective conditions for the sterilization process.

We perform microbiological analyzes in the field of determinations

  • The total number of aerobic microorganisms
  • The total number of yeast / mold
  • Presence / number of Escherichia coli
  • Presence of Staphylococcus aureus
  • Presence of Pseudomonas aeruginosa
  • Presence of Salmonella
  • Clostridium presence
  • Presence of Candida albicans
  • Presence / number of tolerable bile Gram – negative bacteria

We carry out tests by:
–  Ph. Eur.
–  PN-EN ISO 11737-1:2007