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Focusing on a product-centric approach is the path towards EU MDR compliance

The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards like the new EU MDR and MDSAP regulatory changes have evolved, so too has the weight of the burdens these leaders face.

Traditional tools and old-fashioned approaches have not sufficiently lightened the load. Instead, they inadvertently add to it by promoting 3 key problems:

1. Disconnected quality and product records
2. Persistent silos of quality, engineering, operations, and related product teams
3. Adoption of static methods to manage complex quality processes

Complying with these mandates is a key objective of quality leaders, but many underestimate how significantly their work impacts other teams. The design, production, installation and service departments inside medical device manufacturing companies must overcome these issues to reduce compliance risks and remove barriers that impede innovation.


A document-centric approach just won’t work anymore

Document control is critical to success. Despite this fact, traditional stand-alone QMS systems address only a subset of what’s needed, focusing only on two fundamental areas of compliance:

1. Documentation control for SOP’s, specifications, and other files.
2. Process enablement and tracking for auditable processes (including CAPA, requirements management, and training records).

Paper-based processes fail to capture or connect quality management processes to the comprehensive product record often comprised of hundreds if not thousands of mechanical, electrical, and software components, such as assembly and test procedures, and other documents specified in a product’s bill of materials (BOM).

A document-centric QMS approach will not suffice for medical device companies who develop and sell complex products. Products that have a mix of electrical, software, and mechanical components must bring cross-functional teams and designs together to prevent product issues from arising too late in the NPI new product introduction process. Providing traceability between all aspects of the design and quality elements to be able to track, control, and release product design changes to market quickly and effectively is a must.

Remember, they must also be able to address product failures to identify, analyze, and resolve issues.

Go beyond the limits: Adopt a product-centric approach

While still providing the benefits of automated document management, a product-centric approach to QMS is ripe with benefits because it enables complete control throughout your new product development and introduction (NPDI) process.

Medical Device PLM achieves this by aggregating the entire product record and connecting it to quality processes within a single system. At the heart of every medical device company’s product is a complex, relational BOM specifying hundreds or thousands of interrelated components, subassemblies, and associated documents required to test, build, and ship your products to market. This approach addresses quality system requirements in a more traceable, controlled, and connected manner allowing all teams to view the design and related quality records without having to refer to multiple disconnected systems.

Here's an overview of the benefits:

  • Acceleration of your product launch process
  • Streamline regulatory compliance
  • On-time shipment of reliable, high-quality products
  • Tighter control of your product design
  • Reduced costs and improved compliance
  • A common platform enabling cross-functional team collaboration and continuous improvement

A product-centric QMS solution enables complete control and traceability throughout the new product development and introduction (NPDI) process with unified quality and product record management.


Bring disconnected teams and siloed systems together

Many companies develop or implement systems as they grow from smaller to more mature companies. This approach typically involves use of point solutions such as Word or Google documents, email, spreadsheets, network servers, file services, CAD design systems, or other homegrown solutions. This creates a patch-quilt system of silos to manage product and quality records. And, these systems lack a single controlled place to manage all related records by impacted teams.

What does working in disconnected silos look like?

  • Mechanical, electrical, and software engineers design in different tools that are used by their individual teams.
  • Quality teams use document management or other quality management tools that are controlled and accessible only within their workgroup.
  • Manufacturing and customer support teams use a variety of systems to handle planning, sourcing, and service.
  • All these teams have to rely on passing or sharing information via email, shared servers, or cloud storage.

These disconnected silos make it difficult, if not impossible, to identify the latest design and track quality or manufacturing issues. Furthermore, executive management teams cannot get a complete picture regarding NPDI process performance and risks.

Maintain traceability and transparency at all times

Address quality issues quickly and with confidence. With products that focus on patient health, it is imperative to be able to identify, track, analyze, and resolve issues quickly and effectively. Many companies rely on tribal knowledge and manual or siloed processes that introduce communication delays or risk of human error. The best approach is for companies to be proactively prepared to:

  • Confidently and efficiently trace issues back through design
  • Quickly identify causes and remedies of the immediate issue
  • Prevent issues from recurring with other patients or markets
  • Avoid the impacts of recalls, field service repairs, and elevated risk exposure


Avoiding the agony of audits

Audits are a constant reality for medical device manufacturers and drive the critical need for traceability and transparency. How well a team performs during internal or external audits can determine not only the success of the product but sometimes a company’s very existence. Having the full product design history and all quality records tracked in the same system gives everyone the confidence to respond to audits effectively.

Setting the stage for success and innovation

The burden placed on quality and operations leaders to introduce compliant and innovative medical devices is significant. Medical device manufacturers can reduce this burden and at the same time improve quality and product realization by following two principles.

Efforts and actions that focus on meeting FDA regulations and ISO standards should not be carried out or managed in isolation. To effectively compete, medical device manufacturers need to adopt holistic, connective approaches and tools for managing quality processes.

Regulated companies around the world are reaping the rewards of product-centric QMS to:

  • Accelerate NPDI processes and get high-quality products to market faster
  • Expedite readiness for regulations and requirements
  • Go beyond the limitations of document-centric approaches to QMS
  • Connect systems and eliminate disconnected teams and silos
  • Maintain traceability and transparency at all times


To see how Medical Device PLM can help your company, schedule a demo today!


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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