Medical design controls and risk management

Ease your traceability and compliance

Is your traceability matrix on a spreadsheet? Are you documenting regulatory compliance after the product is ready?

– We help organizations bring better ways of working to life, not just on ”paper” but with fully digitalized processes and automation. The best part is that you don’t need to change much!

See a summary how it is possible

Requirements for design and development process

If the world of medical or in-vitro diagnostics devices or heatlhcare software is new to you, then the first part is to really understand the requirements for processes and documentation needed. It is a lot of documentation (even >70% of project work) and making sure of information traceability (20% total effort). Here is a summary:

• Document how you design your product (intended use, needs, requirements, design, architecture)
  • Such requirements need to include relevant standards (safety, cybersecurity, usability, etc.)
• Plan how you verify that the product corresponds to the requirements – and really show traceability to them
• Plan how you validate that the product functions the right way and user needs are met. Again show traceability to user requirements.
• Record the results and evidence of verification and validation
• Identify, control and prevent possible hazards that may take place with your product – and document the risk management process so that is shows traceability to design artefacts and defines your risk mitigation actions, plus shows evidence of their effectiveness
• Carry out design reviews and officially approve documents and/or artefacts prior to advancing to following design phases
• Work under your general quality management system (QMS) and its standard operating procedures (SOPs)
  • Document how you work and gather evidence that you actually worked that way

In brief, there are a lot of things that need to be documented and processes to be followed. Otherwise the product does not get to the market. Period.

Problems with scattered information and lack of traceability

Often working processes are a result of an evolution. We have seen many examples like this:

It may take several forms, but there are some common characteristics that cause problems and inefficiency:

• Information is stored in multiple different places – even finding it may take time!
• Traceability is manual – so it does not help you, but maintaining it takes constant effort
• There is a lack of unified and clear ways of working
• Quality is a separate layer on top of everything, and it just tends to make things stiff
• Document reviews and approvals need freezing of certain things, which causes long waiting times
• Changing anything is error-prone, plus making a change causes a big overhead of manual updates and bureaucracy

Digital design controls for end-to-end traceability

It’s quite clear that in the modern digital era there must be a better way! Over the years, working with a number of medical device and software manufacturers we have perfected our approach.

Taipuva’s solution combines several critical ingredients of success:

• Ready-made digital solution, with industry best practises
• Capability of unifying all the needed processes and information
• Quickly adjustable to make a perfect fit to your exact ways of working
• Service engagement that fits you: we can work together to drive your improvement, or you can just take our solution

We have a track record of getting our customer productive in one week!

The figure above illustrates the main process areas in our solution. Software architecture and detailed design belongs under ”Design Specification”, and therefore the requirements of IEC 62304 are fulfilled.

Additional process areas that we can easily incorporate:

• Digital quality management software (eQMS)
• Product management, with roadmaps, features, versions and variants (product line engineering)
• Software release management
• Agile software development, DevOps and SAFe (enterprise agile)

Feel free to ask us, if you have some questions what’s possible and how it all works!

Advice on medical R&D best practises

With Taipuva as your process improvement partner you will get real results in just few weeks! We solve all your needs:

• Knowledge how the requirements of ISO 13485, ISO 14971 & IEC 62304 translate to development teams
• Experience how to comply in a very efficient and agile way
• Expertise how to bring processes to life with digital tools

Message us an inquiry!