Five Best Practices for Effective Design Controls
Blog | December 30th, 2022

Five Best Practices for Effective Design Controls

Medical device manufacturers focusing on the safety and effectiveness of their products must start at the “design stage” of the product development lifecycle. Of course, there is also a regulatory requirement to establish design controls that acts as proof or evidence that the product being developed is designed for both patient safety and meeting customer requirements.

ComplianceQuest published a whitepaper, “Design Controls in the MedTech Industry,” that highlights the role of documentation, design controls, compliance and collaboration between engineering and quality teams across the product lifecycle.

Having an automated design controls solution enables the following:

  • The process of document management and compliance becomes easier
  • There is an “always up-to-date” set of design files across the product design and development lifecycle
  • These files can be easily shared with multiple stakeholders across teams
  • It helps your quality and engineering teams stay in sync with a single source of truth for all your product design activities
  • Proactively address product risks and requirements traceability

In this blog, we will focus on the five best practices for effective Design Controls that medical device manufacturers must implement.

In the United States, Design Controls 21 CFR 820.30 Regulation applies to all Class II and III devices and some Class I devices, including devices automated with computer software, protective restraints, surgeon’s gloves, manual radionuclide applicator system, tracheobronchial suction catheters and radionuclide teletherapy source.

Best Practice #1 – Design Controls – From Research To Commercialization

In the case of pre-market products, ‘design control’ activities start immediately after the feasibility of a concept, while ‘design change control’ is more relevant during and after production activities.

Having design controls across both pre-market and post-market phases helps establish the safety and efficacy of the product. It also makes it easy to get marketing approval from regulatory authorities.

With automated design controls, it also becomes easier to perform post-market surveillance, conduct vigilance activities and prepare a PSUR (Periodic Safety Update Report) – which is a pharmacovigilance document.

A robust design controls process helps:

  • Streamline verification and validation activities
  • Eliminates the cost of rework
  • Makes the design transfer process smooth
  • Ensures hassle-free commercialization
  • Takes care of regulatory requirements

Best Practice #2 – Integrating Design Controls and Supplier Management

At ComplianceQuest, we organized a webinar titled ‘Moving Beyond ASL with Design Controls and Supplier Management’. The key focus of the webinar was to highlight the role of supplier quality in medical device manufacturing. It is critical for engineering teams to take supplier quality into account right at the design stage. We need to make sure that engineers don’t include components in the design, that doesn’t have a supplier who has been approved for quality.

In the webinar, we talked about upgrading your ASL (Approved Supplier List) to an Approved Manufacture Listing (AML) that fits into your quality plans.

Level 1 and 2 manufacturers (suppliers) can impact your product risk, design and risk control requirements. Vetting all suppliers is imperative to reducing the chances of incorporating incorrect parts into the product design. Having integrated design controls and supplier management solution can make a significant difference to quality performance.

Best Practice 3 – Use a Checklist to Understand Design Controls “Input and Output” Requirements

Establish and maintain Design Input procedures that address user needs and intended uses in measurable terms and address incomplete, ambiguous or conflicting requirements. While the outcomes of a design endeavor are known as design outputs, including the work produced after each design phase is important. The design output procedure must define and describe in ways that make it possible to assess how well it complies with the design input.

At CQ, we put together this checklist to make life easier for engineering and quality leaders. Download it here:

Best Practice # 4 – Integrate Quality Management with Product Design

Quality must become a core part of product design. A quality management solution with an integrated product design solution helps with measuring and tracking quality right from the first step of the design process. Integrating quality and design helps with Failure Mode and Effects Analysis (FMEA), standardized bill of process, work instructions, quality inspection, supplier collaboration, compliance and risk management.

Best Practice # 5 – Automate Design Controls to Drive Efficiency and Improve Traceability

Digitizing and automating the design and development of medical devices reduces the chances of incurring high costs and waste of resources. Automation also improves efficiency, reduces costs and helps optimize resources.

ComplianceQuest’s Design Controls solution offers complete manufacturer visibility over the product design process, making it easy for design teams to collaborate and design high-quality products while guaranteeing compliant and comprehensive documentation.

Cloud-based Design Controls Solution from ComplianceQuest

ComplianceQuest offers a cloud-based Product Design Management Solution that allows businesses to manage design controls effectively. Integrated with the CQ EQMS, the CQ Product Design Management Solution offers instant access to risk management and documentation solutions, among others. With CQ’s Product Design Management Solution, customers can –

  • Gain 100% visibility and traceability of the product development process, thus improving time-to-market
  • Exercise better control and collaborate easily with other team members over design inputs, requirements and risks to improve product quality.
  • Streamline the process of compliance documentation and regulatory requirements, including FDA and ISO
  • Leverage other EQMS features such as document, change, CAPA and management review

To know more about CQ’s Design Controls Solution, you can request a demo here:

Request a Free Demo

Learn about all features of our Product, Quality and Safety suites. Please fill the form below to access our comprehensive Demo Video.

Please confirm your details


Related Blogs

Request Demo