Product Development – Medical Products

You require efficient and effective development of a medical product? Here is how we can help:

  • Project Portfolio Management (Product strategy planning)
  • Product development project management. (From first idea to registration and successful market launch)
  • Validation of; Means of Production, Computer Systems, Test Methods, Hygienic Processing etc.
  • Development and validation of production lines and facilities.
  • Development processing of both software and hardware that meet relevant standards.

Approvals - Regulatory Affairs

You want to quickly bring a medical product to market in several countries? Let us support you in:

  • CE – marking
  • Clarification of international approval requirements
  • Drafting of registration dossiers, e.g. FDA 510(k)
  • Obtaining the necessary approvals

Quality Management

For aiding you in

  • optimizing your internal procedures
  • reorganising your QMS, adapting or adjusting to standards. (e.g. ISO 9001 to ISO 13485; Application of Usability to IEC 62366, FDA QSR etc.).
  • preperation for an inspection (e.g. from the FDA) or an audit,

we can supply exerience with:

  • Technical analysis of products and processes
  • Technicalities of Due Diligence (e.g. Acquisitions, License Agreements)
  • Auditing and Gap Analysis.

The guidelines for ISO 13485:2003 and 21 CFR Part 820 allow us to assist you in the planning and implementation of internal audits.

Project Management

On a variety of projects, we have been aiding our clients in supervising or outsourcing of task packages (e.g. monitoring of changes during development, internationalisation or localisation of labelling, etc.).

Risk Management according to ISO 14971

We offer our clients broad support in the:

  • Presentation of risk analysis and FMEAs
  • Construction of the Risk Management file;
    • Risk Management Planning
    • Risk Analysis
    • Risk Evaluation
    • Risk Control
    • Evaluation of production information from the post production phase.
  • Traceability of all actions during the complete production cycle

Workshops/Training/Coaching

We can provide staff training in the following areas;

  • Processing
  • Project and Project Team Working, Creativity Techniques (e.g. Brainstorming)
  • CE-Marking
  • FDA 510(k) Approvals
  • GMP – Training
  • Technical Documentation, Content Review

Training seminars are conducted In-House.

We are also more than happy to run workshops that allow you and your colleagues to work on an issue in either the classic moderator form or using modern innovative moderator techniques. (e.g. storytelling).

To enhance the reception of the offered knowledge, we can also provide coaching for you and your colleagues in your daily work (e.g. offering reviews in the drafting of documents).