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The value of traceability when working with regulation and documentation in the design process

Context (and traceability) is king


In one of my earlier posts here on the blog, I complained about how hard my previous job as an engineer at a medical device company was. Spoiler alert: We simply lacked the right tools to get the work done in a more efficient manner.

And nothing was more frustrating when the time came for us to obtain approvals for designs to ensure that governing regulations have been met. Let me tell you why.


Required documentation

As you might know, obtaining approvals for medical devices can involve the creation of several documentation sets, all under the review and governance of regulations such as FDA CFR Part 820 and the EU MDR.

Specifically, requirements for quality management, where a manufacturer needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, are structured in these sets. For example:

  • The Design History File (DHF)
  • The Device Master Record (DMR)
  • Device History Record (DHR)

These documents describe the entire lifecycle of a device, from concept and stakeholder requirements, to design development, hand-off to manufacturing, and the history of a specific unit or batch. A best practice is to show the relationships and linkages between stakeholder requirements, design inputs and outputs, and between design verification and validation in a traceability matrix.


What we did

What we usually did was often gather these documents from various siloed sources at the end of design and incorporated into several large binders that attempted to describe the documents, decisions, and changes that occurred during the design efforts. In addition, large spreadsheets were created that again tried to capture traceability in the design intent, process, and results.

The overall problem with this approach was that all design efforts are iterative processes with many changes and reworks along the way. Capturing the many changes that occur simply became a maintenance nightmare for the spreadsheet owner. That was me!

What we should have done

We should have had access to a system that allowed us to create as many regulatory structures as we wanted to manage and have them managed in the same way so that they are automatically created, tracked and baselined. Other document structures such as the Technical File could also benefit from being managed in the same way as the DHF and the DMR.

Quite frankly, such capability should be a standard requirement in the medical device industry, if you ask me. 


That is why we developed Minerva PLM

In Minerva PLM we have developed this feature. In this video, I will show you how you can handle these document structures in the same way with the same requirements for change management and traceability and achieve:

- Accurate project update status

- Faster documentation retrieval and more assured regulatory compliance by capturing product data as it happens, not as an afterthought—risk avoidance

- Efficient regulatory submission workflow that is futureproofed. Face an audit with confidence knowing that information is held or federated into a single knowledgebase, readily available

- Decreased risk of errors and improved product quality and support with the ability to rapidly respond to changing customer demands.

Featured Whitepaper: Design Control in the Medical Device Industry

About the author

Thomas Skogen

Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.

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