QA Services

  • Implementation and improvement of QA systems, including all the aspects required during product development and manufacturing, using tests during the R&D process, technology transfer, and guidance throughout the entire supply chain.
  • Development of a QA system suitable for each stage in the product’s lifecycle and that ensures usage of suitable methods for medical uses and commercial applications.
  • Assistance in identifying critical quality attributes for efficiency, safety, and effectiveness maximization.
  • Identification of regulatory requirements in accordance with a product’s intended field of use. Guidance & counseling for optimization of our clients’ QA systems using efficient implementation of current standards, such as FDA guidelines, ISO 13485, ISO 9001, CMDCAS, EU MDR, ISO 14971, GMP, QSR etc.
  • Counseling for determination of critical product specification requirements and key characteristics for the evaluation of its efficiency.
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