Medical Technology

Implementation and Development of your QM System

At TopQM-Systems we can account for numerous customer projects in the field of medical technology in our more than 15 years of experience in the implementation, training and optimization of branch-specific QM systems.
We develop comprehensible, simple and meaningful QM systems according to the proven 5 TopQM-Systems project phases, starting from the early stages all the way to successful certification.
Minimal use of paper, meaningful management tools and a practicable QM-system tailored to suit the company are the benchmarks for your and our success.
We not only show up necessary improvement potential, but provide suggestions for realization, or solutions, respectively, too.

 

We offer support in the following standards:

  • ISO 13485 (QM system for medical technology)
  • ISO 9001 (quality management)
  • EU directive 93/42/EWG on medical products
  • EU ammending directive 2007/47/EG
  • Risik analyses
  • ISO 14001 (environmental management)
  • OHSAS 18001 (occupational health and safety)
  • Project management, scheduling and milestone planning
  • Planning for new parts, ramp up management
  • IMS integrated management system (combination of process-oriented and branch-specific standards)

Independent TopQM Certification Service

Trust TopQM-Systems in the implementation and development of your desired QM system. Take care of your daily business while we take care of your desired QM system. A great advantage for our customers is that we at TopQM-Systems collaborate completely independently with recognized, accredited certification bodies according to which certification body is best suited to your company.
We take on the complete organization of your certification project at a guaranteed fixed price all the way to successful certification:

  • Project management and scheduling
  • Preparation of the complete QM documentation
  • Implementation of existing QM forms
  • Employee training
  • Internal auditor qualification
  • Enquiries, selection of the certification body and the respective auditors
  • Presentation of certificate

Competence + Experience = TopQM-Systems

TopQM-Systems can already refer to numerous, successfully completed projects in the field of medical technology. Following are some project examples, which have invariably been realized optimally and verifiably to the utmost satisfaction of our customers:

  • Manufacture and distribution of general medical products of the respective product classes
  • Trading house and import of medical products
  • Manufacutrer and supplier of implants
  • Trading house for orthopaedic technology
  • OEM for emergency services and emergency vehicles

More reference projects from our reference list can be found here: TopQM-Reference List available for download
We would be happy to provide you with detailed information on the respective projects giving the particulars of the relevant contact person upon request.

 

In-house Training and Workshops

At TopQM-Systems we offer, apart from project and certification support, company-specific in-house training.
The training content is always current and is based on experience, our know-how and our daily activities from customer projects. Thus we ensure interesting and current training content and a high level of learning success with your employees.

Training topics and project support:

  • Foundation and basic knowledge of ISO 13485
  • Foundation and basic knowledge of ISO 9001
  • Qualification as internal auditor
  • Technical cleanliness
  • Risk analysis according to FMEA, HAZOP or HACCP
  • Determination of customer satisfaction
  • CIP (Continuous Improvement Process)
  • Defect management and complaints processing
  • Supplier evaluation
  • Management review

More information on attractive compact seminars adapted to your needs are available upon request.