Your trusted technical service provider in the area of medical technology

DeviceMaster GmbH is an association of experienced consultants who decided to create a young competent multilingual project team. We complement each others areas of competence and cover a vast expanse of activities in the medical technology sector targeting international market approval, smooth development of law-conform technical files, setting up a state-of-the-art quality management system as well as developing customized system and hardware engineering solutions.

Your benefits:

  • Specialized know-how in the field of clinical evaluations, biological safety, safety concepts for active medical devices, product verification, international market approval and the Medical Device Regulation.
  • Efficient solutions through effective partnerships and communication
  • Extensive experience and readiness of our experts
  • You save resources thanks to a results-oriented project management

What makes us skilled and attractive

  • Adopting advanced professional project management tools and techniques provided by PMBOK (Project Management Body of Knowledge) in every facet of our work.
  • Providing flexible solutions, efficient processes and optimal outcomes
  • Securing sustainable solutions to complex scenarios
  • Growing association of experienced project managers, regulatory experts and technical specialists
  • Benefitting from open and trusty relationships
  • Enjoying the advantages of a modern IT infrastructure tweaked for close-knit collaborations

Our current offers for you

Working with the DeviceMasters means handling projects effectively and efficiently in order to achieve amazing outcomes. We constantly adapt and tailor our services to customized packages and are happy to offer you these deals.

Class One Product Services – MDR

The transition period to the new Medical Device Regulation runs out in May 2021. Placing new products for the first time in the marketplace means that your technical documentation and your quality system need to meet the requirements of the MDR. The new device class Ir for reusable surgical equipment stretches the existing sub-classes Is and Im within the risk class I, increasing the layer of complexity for the manufacturer.

Legacy Devices

You have indicated a service life of 8-10 years for your medical equipment and as a manufacturer have to guarantee the safety of your devices throughout their life-cycle. Legislative authorities worldwide have defined requirements to legal manufacturers, for instance in the areas of market surveillance, risk management and clinical evaluations. Added to these conditions is the situation that your products are no longer being manufactured or sold, but considerable resources still have to be allotted for regulatory and technical support. It is often your most experienced employees that are working on these issues.

Expertise

QM Conformity

A high-performance quality management system is a decisive contributing factor not only for the success of medical devices in the marketplace but also for the organizational sustainability in the medical technology sector. We help ensure the development of your QM system to the highest standards in compliance to the recently harmonized ISO 13485:2016 as well as the global health and medical regulations such as the European MDR and the FDA body of rules and regulations.

Technical Documentation

We ably prepare your technical files to comply with current regulatory requirements. Benefit from our extensive experience in international market approval submissions, risk management and clinical evaluations.

System and Hardware
Engineering

Realize your design ideas and profit from our medical technology competence. Product safety, risk control and usability are the most valued assets in developing medical devices from your ideas.

Project Management

A high-quality project management preserves resources and creates open spaces for ideas and creative forces. We use an open approach in our customer relationships and are consequently driven by goals and objectives set out for us.

Our services

QM Conformity

  • Harmonizing quality management systems
  • Implementing QM systems
  • Transitioning QM systems to
    ISO 13485:2016, 21CFR part 820, MDSAP or ISO 14001:2015
  • Designing audit programs
  • Conducting audits:
    • Internal system or process audits
    • Supplier audits
  • Developing standard operating procedures (SOPs) as part of harmonizing the QM system

Technical Files and Risk Management

  • • Compiling and maintaining technical files
    • Usability
    • Hardware and software files
    • Risk management files
    • Biological evaluations
    • Clinical evaluations
  • Reviewing SOPs
  • Updating the technical files to the requirements of European MDR
  • Maintaining and expanding technical files of legacy devices

System and Hardware Engineering

  • Reducing environmental impacts during product development, manufacturing, sales and operation of medical devices
  • Applying usability requirements to medical devices
  • Securing electronic and electro-magnetic safety
  • Ensuring regulatory compliance of alarm systems
  • Performing design verification and validation

Project management

  • Project life cycle management
  • Identifying stakeholder requirements
  • Establishing project communication
  • Providing status reports and ongoing planning activities
  • Conducting document management
  • Application of PMBOK Guide tools and techniques

Service catalog by standards

ISO 9001

ISO 13485

FDA QSR
(21 CFR 820)

ISO 19011

ISO 17021

ISO 60601-1-X

ISO 14971

ISO 62304

ISO 62306

ISO IEC 80001

ISO 21500

ISO 10006

ISO 62366

ISO 9241

FDA 510(k)

MDD 93/42/EEC

CMDCAS GD210

JPAL

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We offer interesting and diversified jobs

Visit us

Rauentaler Str. 22/1
76437 Rastatt

Call us

Phone +49 (0) 7222 156 7799
Fax +49 (0) 7222 156 7801