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Key Highlights:

  • Design Control can improve the product design, making it safer right from the word go. This can also reduce the need for rework later.
  • Design Control is also a regulatory requirement. Therefore, companies in the life sciences industry need to have a clear process to improve the product life cycle right from the time of design.
  • Automating the design control process and integrating it closely with the product development process is made easier with an EQMS solution like the one from ComplianceQuest.

Introduction

Product design is an outgrowth of industrial design, which focuses not only on the appearance of a product but also on how it functions, is manufactured, and ultimately the value and experience it provides for users. In the life sciences industry too, product design and development play a critical part in the overall product life cycle. From research to prototyping, product development, and subsequently fulfilling user needs, product design is crucial for both patients and healthcare givers -because, it governs the safety and usability of the medical device, ensuring trouble-free operation.

Another aspect to consider is the environment -an in-depth understanding of how users will interact with a medical device within their environment is vital for a good design.

Design Control – A Regulatory Requirement for Medical Device and Lifesciences companies

One of the major factors in a product recall (in the life sciences industry) is faulty design, followed by software issues, and non-conforming materials/components. Design control is also a regulatory need and manufacturers have to comply with the US FDA 21 CFR 820.30 subpart C and ISO 13485 clause 7.3.

With the advent of Industry 4.0 and opportunity to digitalize the quality management system, it’s high time medical device companies to identify and invest into a cloud based EQMS including a design control module.

ComplianceQuest recently published a whitepaper on Design Control, explaining the vital role it plays in both pre-market and post-market device development, and how an EQMS solution such as the one from ComplianceQuest can help manufacturers meet requirements and prevent unexpected problems.

Read Whitepaper

Every country has a clause related to design control, and depending on where a company’s products are being marketed, the manufacturer will have to ensure compliance with those regulations too.

Global regulations expect the organization to

  • Document, implement and record the design phase or design controls process throughout the product development process
  • Establish a set of written procedures and implement them during the device design process
  • Define the interfaces, responsibilities, and activities affecting device design
  • Review, document, approve, and update as developments and change controls evolve
  • Ensure that device design is controlled, risks identified and mitigated to the extent practically possible, and confirm that the design is correctly transferred into production

Quality Management of Design

In the current stringent regulatory regime, the organization must exhibit “extra” carefulness with design control activities, particularly in the case of high-risk devices. This has to happen right from the research and development phase all the way to manufacturing and marketing.

Exhaustive scientific and clinical data should be collected or generated, as appropriate, from various sources and methods that may include customer feedback, complaints, suppliers, deviation in the production process, CAPA, internal audits, quality control activities, clinical studies, post-market surveillance, vigilance, etc. This is critical to establish the safety and efficacy of the product and to obtain marketing approval from regulatory authorities. The manufacturer will necessarily perform post-market surveillance and vigilance activities and PSUR [Periodic Safety Update Reports] to provide safety and effectiveness oversight for the lifecycle of a device.

Prior to the initiation of the design phase, the first thorough control of a medical device should be the implementation of Quality Management System (QMS) requirements to ensure the product is developed after completing all the necessary reviews, environmental consideration, verification and validation activities. Combining quality with risk management processes and implementing them as early as possible in the design of a medical device can be an effective strategy to minimize residual risk.

Need for Automation with the right EQMS

Performing design and development activities manually is very labor-intensive, error-prone, and has high chances of rework. It can increase the cost, cause wastage of limited resources, delay the commercialization process and contribute to loss of business. Therefore, having a validated cloud-based EQMS solution would be a long-term asset.

A cloud-based EQMS solution such as the one from ComplianceQuest includes a design control module that plays a role in pre-market and post-market device development. It ensures that the device is compliant with user needs, its intended use, other specific requirements, and prevents unexpected problems. Designed to align with regulatory requirements, the ComplianceQuest solution helps businesses improve product quality, lowers the cost of quality, improves compliance as well as enhances brand reputation, leading to faster growth and revenues.

To know more, visit our page on Design Control.

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