Regulatory

Regulatory

Software used in healthcare settings is sometimes viewed and regulated as a medical device - specific national legislation applies to such software. Trifork eHealth is specialized in developing Software as a Medical Device (SaMD).

At Trifork eHealth, we excel in the development of certified solutions that address the unique issues and requirements in an increasingly complex healthcare IT environment. We have extensive skills and experience in software regulated as a medical device and software development in coherence with regulatory requirements and international standards:

  • IEC 62304:2015
  • ISO 14971:2012
  • IEC 82304-1:2016
  • IEC 62366-1:2015
  • ISO 13485:2016

From idea to market

From idea to market with a software as a medical device can be a complex task if not done properly. Our projects follow the 8 steps below in iterations until we have found the best suitable path to market access:

Initial regulatory considerations

1 . Medical Device Determination (consumer/fitness device vs. medical device)
2. Medical Device Classification (Class I, IIa, IIb or III)
3. Software Safety Classification (Class A, B or C)

These steps have an enormous impact on the development process and dictate the detail level in the architecture, the test- and documents level and the product assessment procedure – you as a manufacturer can 100% control the above with the right go-to-market strategy and the necessary segregation in the software architecture. All options should be considered and weighed early on.

Agile Software Development

4. Identify and fulfill applicable essential requirements

Trifork eHealth identifies all the applicable essential requirements for the software – and identifies relevant harmonized standards to comply with the requirements.

Our agile software development process is in coherence with regulatory requirements and international standards and allows our costumers to change their mind as we gain more insight into the solution.

CE marking

5. Compile ‘Technical documentation’ (TCF)
6. Get an assessment (if required)
7. Sign declaration and register at the the company
8. Apply the CE mark

All development and tests are continually documented and the technical documentation is compiled in accordance with the conformity assessment procedure for the product.

The last three steps are typically handled by our customers themselves – but Trifork eHealth helps and assists all the way to putting the product on the market.

Trifork eHealth partners with FORCE Technology, TPU and Prevas

Certifications, such as obtaining the CE mark for SaMD, can be challenging for both small and large players in the industry. Trifork eHealth has sound experience and expertise in the classification process of Software as Medical Device. In the new cooperation with FORCE Technology, we can lead the certification process of your software covering risk Class I, Class IIa, Class IIb and Class III with software safety classes A, B or C. In a new cooperation with TPU and Prevas we also support the development and market approval where hardware components are involved.

We use standards and guidelines applicable to the European and US legislations

Standards

  • ISO 14971:2012: Medical devices – Application of risk management to medical devices
  • ISO 13485:2016: Medical devices - Quality management systems – Requirements for regulatory purposes
  • IEC 62366-1:2015: Medical devices: Application of usability engineering to medical devices
  • IEC 62304:2015: Medical devices software – Software life-cycle processes
  • ISO 15223-1:2012: Symbols to be used with medical device labels, labelling and information to be supplied

Directive

  • Medical Device Directive 93/42/EEC (valid until 2020)

Regulation

  • Medical Device Regulation EU 2017/745

Hosting (private/public cloud)

  • ISO27000
  • ISAE3402
  • ISAE3000
  • Compliance to ITILv3

Guidelines

  • MEDDEV 2.1/6: Qualification and Classification of Stand alone software
  • MEDDEV 2.4/1 rev. 9: Classification of medical devices
  • MEDDEV 2.7/1 rev.4: Clinical evaluation

CE-certification

Trifork eHealth has experience with certifications for Software as Medical Device. We work closely together with FORCE Technology , Prevas A/S and TPU A/S to support customers in regulatory requirements on a global scale.

What do you get?

Example templates for international compliance

  • Use Specification
  • Product Description
  • Risk Management
  • User Interface
  • Clinical Evaluation
  • Usability Test reports and protocols
  • Software Development plan
  • Software Tests
  • Software Architecture
  • Software Verification
  • Software Requirements
  • Software Maintenance
  • Instructions for Use
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Interested?

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