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Regulatory & QM Knowledge Transfer

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Our aim is the clear and effective transfer of knowledge

Knowledge transfer means that we bundle specialized knowledge and transfer this knowledge in a comprehensible way to our clients. The transfer of knowledge is achieved through consulting, coaching, seminars, workshops or Edu-Casts (training videos) on all topics related to Regulatory Affairs & Quality Management. Graphics, overviews and feature publications complete the Knowledge Transfer.

Consulting and Coaching

Whether only a brief consultation or comprehensive coaching is required, regular services supports the implementation of national and international regulatory requirements in the area of Regulatory Affairs and Quality Management Systems for medical device manufacturers. Herewith an excerpt of our competencies and services.

Regulatory Affairs

  • Determine design, structure and content of technical documentation according to Regulation (EU) 2017/745 (MDR)
  • Determine design, structure and content of technical documentation for international approvals
  • Research and selection of applicable European and international regulations, standards and guidelines
  • Guidance on European conformity assessment procedures (CE)
  • Guidance on international certification and registration procedures
  • Assistance in selecting an appropriate conformity assessment procedure under Regulation (EU) 2017/745 (MDR)
  • Strategic advice on product development and approvals
  • Communication with authorities and Notified Bodies
  • Classification of medical devices taking into account intended purpose and indications
  • Support for reporting obligations to competent authorities
  • Support in the selection of suitable laboratories and test institutes for product development and production monitoring
  • Coaching and training of new employees

Quality Management

  • Implement a quality management system according to ISO 13485 / EN ISO 13485
  • Implement a quality management system according to MDSAP (USA, Canada, Brazil, Australia, Japan)
  • Implement a risk management process according to ISO 14971 / EN ISO 14971
  • Prepare the organization for pending QM inspections by authorities or certifiers (Competent Authority, FDA, Notified Body, etc.)
  • Moderate design reviews (development reviews)
  • Moderate management reviews (management reviews)
  • Guidance during external audits (e.g. Notified Body, Competent Authority, FDA)
  • Analysis and implementation of process optimization
  • Creating process or procedure instructions

 

Please feel free to contact us. We will gladly provide competent and individual advice.

Poster

regular services Posters illustrate complex relationships and facts in easily understandable graphical representations. This will allow you to always keep track of the important topics in the field of quality management and regulatory affairs for your medical devices. We also offer educational videos that explain the posters in a few minutes with our new regular services Edu-Casts .

Interested?

Have a look at the sample to visualize how regular services illustrate complex relationships and facts regarding

Quality Management Systems for Medical Devices

Please contact us if you are interested in our posters.

Feature Publications

regular rervices prepares specialized publications covering a wide variety of regulatory affairs and quality management system requirements for medical device manufacturers. Whether it's the professional translation of international publications or the clear description of regulatory requirements, our Feature Publications help you and your colleagues to better understand complex regulatory issues. The focus is on the practice-oriented implementation in your company.
Previous publications:

  • regular services – Feature Publication (NEW)
    MDSAP Companion Document - GERMAN TRANSLATION
  • regular services – Feature Publication (NEW)
    Statistical Methods - German
  • regular services – Feature Publication
    Regulation (EU) 2017/745 (MDR) - German - Table of contents and hyperlinks to definitions
  • regular services – Feature Publication
    NBOG document 2010-1: Supplier auditing - GERMAN TRANSLATION
  • regular services – Feature Publication
    21CFR820 (QSR) - GERMAN TRANSLATION
  • regular services – Feature Publication
    FDA's QSIT (Quality System Inspection Technique) - GERMAN TRANSLATION
  • regular services – Feature Publication
    GHTF / SG3 / N18 / 2010: CAPA - GERMAN TRANSLATION
  • regular services – Feature Publication
    Biological safety for sterile products - overview of normative requirements - German

Please contact us if you are interested in our Feature Publications.

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