QM systems

MDR

ISO 13485

ISO 27001

FDA  21 CFR 820

ISO 9001

ISO 14971

Sample processes

for QM systems

Our preconfigured sample processes and templates cover 100% of the requirements of the latest versions of standards and guidelines.

  • ISO 13485
  • MDR
  • 21 CFR 820
  • ISO 14971
  • ISO 27001
  • ISO 9001

 

The requirements of different QM systems overlap, complement or differ.

So that you don't have to work with different processes in different regions, we harmonize them for you.


to product-specific standards

Our sample processes also include the following QM-supporting or product-specific standards:

  • Software development compliant with ISO 62304
  • Validation of software for quality systems of medical devices ISO/TR 80002-2,
  • FDA Guidance Cybersecurity in Medical Devices and 21 CFR part 11
  • Clinical assessments in accordance with MDR and MEDDEV
  • Usability in accordance with ISO 62366
  • CAPA compliant with FDA and Global Harmonization Task Force (GTHF)
  • FDA- Inspection; specifically for the preparation and implementation of your FDA audit

Further product-relevant regulations can be implemented at short notice.

The GAP analysis

We carry out gap analyzes and update or add new regulations.



for existing QM systems

  • Identification of gaps
  • Supplementation of QM requirements
  • Extension to other QM systems e.g. ISO 27001 or 21CFR 820



to product-specific standards

  • Identification of applicable standards/guidelines, e.g. for approval in additional regions,
  • Implementation of additional regulatory requirements

auditing

 Audits check compliance with regulatory requirements as well as the efficiency and effectiveness of their implementation. We support you in planning, implementation and post-processing or carry these out for you as an independent partner: 
  • Internal QM audits
  • Production audits
  • External supplier audits
  • Mock audits
  • Planning the audits
  • Target coordination
  • Execution and documentation
  • Post- and further processing of the audits, e.g. for evaluation by management.

ISMS

The task of an information security management system (ISMS) is to ensure information security in a company. To ensure its safety, it must be controlled, monitored and continuously improved. We support the


  • Identification of your assets
  • Categorization of threats and their consequences
  • Definition of risk levels
  • Assessment of your assets Collection and development of control mechanisms
  • Information security reviews
  • Monitoring and improvement of information security