A Structural Approach to European Medical Device Regulation Compliance


As the Medical Device Regulation (MDR) approaches implementation, industry reports show that many organizations are still unprepared as they endeavor to grasp their obligations. Especially in terms of their compliance. 

Changes in compliance regulations, such as the European Union’s new Medical Device Regulation (MDR), have resulted in significant changes in how corporations and distributors show product safety and efficiency. Companies must produce clinical proof for all products, as well as systems and paperwork, in order to be compliant throughout the device’s lifetime. 

Companies are reacting in one of two ways: by using contemporary requirement management systems to increase agility and flexibility. Unified cloud requirement management software may assist maintain compliance and encourage engaged collaboration across regions by allowing all aspects to be tracked in one location. With the changing regulatory environment, it is no longer possible to have unrelated material that is not easily accessible.

Traditional equipment and methods have not been effective in lightening the burden. Instead, they unintentionally exacerbate the situation by fostering three key problems:

Quality and product records that aren’t linked

  1. Quality, engineering, operations, and related product teams are still separated by divisions.
  2. Using static techniques to control quality processes that are complicated

Compliance with these standards is a top priority for quality leaders, but many underestimate the influence of their work on other groups. To decrease compliance risks and remove impediments to innovation, medical device manufacturing businesses must address these concerns in their design, production, installation, and service divisions.


Also Read: “Significance of Compliance Management in Modern PLM”

A document-centric strategy is no longer feasible

Controlling documents is crucial to success. Medical device firms that create and market complicated goods will not be satisfied with a document-centric QMS strategy. To avoid product difficulties occurring too late in the NPI new product introduction process, products with a mix of electrical, software, and mechanical components must bring cross-functional teams and designs together. It’s critical to provide traceability across all components of the design and quality elements so that product design changes may be tracked, controlled, and sent to market promptly and efficiently.

Push the boundaries: Take a product-centric approach

A product-centric approach to QMS is rich with benefits since it offers total control throughout your new product development and gives the benefits of automated document management. Medical Device PLM does this by combining all product records into a single system and linking them to quality procedures. A comprehensive, relational bill of materials (BOM) is at the core of every medical device company’s product. Detailing hundreds or thousands of interconnected components, subassemblies, and supporting papers necessary to test, assemble, and ship your devices to market. This method meets quality system needs in a more traceable, controllable, and linked manner. Allowing all teams to see the design and related quality records without referring to several unconnected systems.

Here’s a rundown of the advantages:

  • Accelerating the introduction of your product
  • Streamline the regulatory process.
  • On-time delivery of dependable, high-quality goods
  • More control over the design of your product
  • Cost savings and increased compliance
  • A shared platform that allows cross-functional teams to collaborate and improve continuously.

Bring together disjointed teams and segregated systems

As a company grows from a tiny startup to a larger enterprise, it develops or implements systems. Point solutions, such as Word or Google documents, email, spreadsheets, network servers, file services, CAD design programs, or other homemade solutions, are often used in this method. To maintain product and quality records, this results in a patchwork structure of silos. Furthermore, these systems lack a centrally controlled location where impacted teams may handle all connected records.

Getting rid of the pain of audits

Medical device makers are constantly subjected to audits, which emphasize the need for traceability and openness. The success of a product, as well as the company’s very survival, can be determined by how effectively a team performs during internal or external audits. Everyone has the confidence to respond to audits successfully when the whole product design history and all quality data are tracked in the same system.

Also Read: “The Importance of IoT in Medical Device Development”

Product-centric QMS is allowing regulated enterprises all around the world to:

Increase the speed with which NPDI procedures are completed and high-quality items are brought to market.

  1. Ensure that you are up to date on all legislation and requirements as soon as possible.
  2. QMS solutions that go beyond the restrictions of document-centric techniques are now available.
  3. Eliminate isolated teams and silos by connecting systems.
  4. Always maintain traceability and openness.


How Can KloudPLM Assist You

You may find it daunting to maintain your present quality procedures and assemble all of the essential product data for MDR compliance. Especially if you are dealing with manual, paper-based, or legacy systems.

By connecting all of your product information and quality procedures in one shared platform, an enterprise quality management system like KloudPLM makes meeting compliance easier. Traditional document-based systems, on the other hand, KloudPLM maintains:

Finally, KloudPLM allows your team to spend less time maintaining paperwork and more time focusing on providing creative, safe, and effective products while also improving quality. Schedule a demo right now.

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