DOMESTIC RA

ICMC (International Certification Management Center Co., Ltd.)

Annual Technical Advisory Service

In vitro diagnostic reagents/medical devices (GMP, ISO, RA) annual technical advisory services

ICMC is a RA consulting company specializing in in vitro diagnostic reagents/medical device that has accumulated a lot of experience and information through continuous technical support for RA and certification for more than 25 years.
ICMC provides annual technical advisory services for in vitro diagnostic reagents/medical devices based on licensing expertise. The service can be inquired by professional consultants who have cultivated the latest industry trends and expertise in related specifications without limit to the number of queries per year.




Companies subject to annual technical advisory services

  • In vitro diagnostic reagents/medical devices start-ups
  • A company that is difficult to hire a professional RA or wants to cultivate the expertise of its employees
  • A company that wants to ask freely without disclosing its technology
  • Companies that want to raise the overall level of documents and forms
  • Companies seeking technical support in both fields of in vitro diagnostic reagents and medical devices


Details of annual technical advisory service

1
Consultation on domestic import/manufacturing RA (MFDS)
  • Electrical safety test, performance test, biological test, etc.
  • Analytical performance tests, stability tests, etc.
  • Technical documents and attachments
  • Complementary advice
2
Consultation on in vitro diagnostic reagents/medical device quality management systems (GMP / ISO 13485:2016)
  • Risk management and usability
  • Software validation
  • Design and development
  • Production performance and medical device files
  • Other procedures and forms
  • Complementary advice
3
Consultation on CE-IVDR certification (Regulation (EU) 2017/746)
  • Revision of the CEIVR Act
  • Technical Documentation
  • QMS procedures and forms such as PMS, Vigilance, CE marking, etc.
4
Consultation on CE-MDR certification (Regulation (EU) 2017/745)
  • Revision of the CE MDR Act
  • Technical Documentation
  • QMS procedures and forms such as PMS, Vigilance, CE marking, etc.


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Annual Technical Advisory Service-related matters

Estimates are calculated in consideration of the size of the company or necessary requirements.