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Regulatory Compiance EUR (CE), USA (FDA), Consulting and support to ensure excellent product quality: ISO 13485, ISO 14971, QSR (GMP)

Consulting for medical technology
Since 2000 en.co.tec offers unique solutions for medical device manufacturers and suppliers in the fields of regulatory compliance and quality management. The services support in all stages of the product life cycle. Our experts are medical device technicians and quality engineers who have international industry experience in R & D and production. Our goal is to relieve our customers of the technical details and regulations and to provide a „one-stop-shop“ with modular defined „turnkey“ solutions.

Trainings for medical technology
Since 2008 en.co.tec offers seminars to spread the comprehensive experience and expertise of the medical technology consulting to the medical device manufacturers and suppliers. We offer a wide range of seminars on quality management and regulatory affairs in Austria and Germany. The trainers are medical device and / or quality management experts and provide latest know-how in practice. All seminars are offered as in-house trainings as well.

Regulatory Consulting & Trainings for Medical Device Manufacturers

What we offer

Consulting for Medical Device Manufacturerers and Suppliers
Quality Management Systems: Implemetation, Improvement, Assessment, Internal Audits, Supplier Audits, FDA Inspections, etc.
Technical Documention: Creation and submission of Technical Documention for CE-Marking, FDA Approval.

Trainings for Medical Device Manufacturerers and Suppliers
Open Seminaries, Inhouse Seminaries for Quality & Risk Managament and Regulatory Affairs, various Regulations & Standards (e.g. ISO 13485, ISO 14971, QSR(GMP), EN 62304, EN 62366, MDD (93/42/EC), IVD (98/78/EC), 21 CFR 820, FDA-Inspection Preparation, etc.)

What we are looking for

Established and StartUp medical device manufacturers and suppliers that need support in Quality Management and/or Regluatoy Affairs to bring their Medical Devices to the European or US Market. The Medical Devices can be in all stages of the product life cycle (e.g. Design and Development, Design Tranfer to Production, Expansion to new Markets,...). Especially Mobile Medical App Developers are welcomed.

Keywords

  • Medical Technology
    • [offer] Regulatory services

Collaboration sought

  • Research & development
  • Prototyping
  • Series production

Responsible

CEO, Senior Consultant

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