MEDICAL DEVICES / IN-VITRO DIAGNOSTICS DEVICES

Whether you produce the otoscope or a plaster, Class I medical devices, or an implant of Class III, the same rules are applied in terms of manufacturing, quality assurance, quality control, and registration. The only difference is that for lower risk Class I devices it is not necessary to undergo costly and long CE-marking process with the Notified Body – the self-declaration would be sufficient. However, the self-declaration doesn’t remove the obligation to place the safe and effective device on the market, which is assured by the Technical Documentation compliant with the Medical Device Regulation (resp. Invitro Diagnostic Device Regulation) and the Quality Management System certified to ISO 13485 standard.

In addition to that, it should be kept in mind that since 2019, the unannounced audits will become common, as required in regulations. Therefore, having the documentation always ready for presentation and evaluation will become indispensable for the problem-free business in the Medical Device domain.

Using our long-term know-how and expertise, at PMSystem we offer multiple packages suited to your needs, in order to support you in successfully dealing with the regulatory submissions and audits, in creating and optimizing your Quality Management System and the Design Dossier / Technical File of your Medical Device.

Our efficient strategy based on risk approach focuses on the essential safety and effectiveness requirements to guarantee a short time-to-market and to minimize the effort spent to obtain the certification.

Services

  • CE-marking project management
  • MDR and IVDR transition support
  • Implementation of QMS or upgrading existing Quality Management Systems for compliance with ISO 13485:2016
  • Support with regulatory submissions including
    - Conceptual design
    - Clean room qualification from URS (User Requirements Specifications)
    up to Performance Qualification (URS-DQ-IQ-OQ-PQ)
  • Representative functions such as contracted Quality Manager or Regulatory Affairs Manager
  • Risk assessments
  • Mock audit and third-party audit
  • Systems qualification
  • Training