Nectar Product Development

Regulatory Expectations in Medical Device Development 101

Understanding and adhering to regulatory expectations is essential for successful medical device development, ensuring compliance with industry standards and FDA requirements

Embarking on medical innovation’s uncharted seas is exhilarating. Yet, navigating regulations, like taming a wild sea, is crucial. Nectar becomes your seasoned captain, with ISO 13485:2016 as the navigational chart and FDA rules as the constellations, ensuring a course that blends innovation’s winds with compliance’s North Star.

What are the Key Regulatory Requirements in Medical Device Design and Development?

In the realm of medical device design and development planning, there exists a labyrinth of regulatory prerequisites. The foundational benchmarks are succinctly delineated in section 7.3.2 of ISO 13485:2016 and FDA 21 CFR part 820.32 (c). Let’s delve deeper into these documents to unveil their quintessence.

What does ISO 13485:2016 – Section 7.3.2 entail?

Section 7.3.2 of ISO 13485:2016 zeroes in on the design and development mandates within quality management systems that have applicability in the market. These mandates encompass crucial facets such as:

  • Documentation of design and development stages
  • Specification of review requirements at each design stage
  • Definition of verification, validation, and design transfer activities pertinent to each development stage
  • Allocation of responsibilities and authorities for design and development
  • Establishment of methods to ensure traceability from outputs to inputs
  • Determination of necessary resources, including personnel competency

Nectar is ISO13485:2016 certified

How Does FDA 21 CFR Part 820.30 Emphasize Design Controls and Preplanning?

FDA 21 CFR Part 820.30 places emphasis on design controls—an achievement contingent on meticulous preplanning. This entails the ability to map out milestones, anticipate financial and technical hurdles, and establish a release timeline for your medical device. According to this regulation, every manufacturer is mandated to formulate and uphold plans delineating design and development activities, along with clearly defined responsibilities for implementation. These plans should outline interactions with diverse groups or activities that offer inputs to the design and development process, undergoing periodic review, updates, and approval as the development process evolves.

Infographic that shows the design control process in medical device development. It begins with user needs and ends in a medical device

Why is Integrating Risk Management into the Design Plan Important According to ISO 13485:2016 and 21 CFR Part 820.30?

An indispensable takeaway is the integration of risk management activities within the design and development plan, as stipulated by both 21 CFR Part 820.30 and ISO 13485:2016 section 7.3.2. Crafting a design plan isn’t as simple as generating a Gantt chart; it necessitates thoughtful consideration. While the official guidelines do not explicitly demand anticipated delivery dates, they are commonly expected by manufacturers and businesses. The intricacies of these guidelines necessitate the inclusion of all projected project activities across groups and interactions, delineating core team competencies. Every developmental step should be meticulously documented, complying with design control processes.

What is a Quality Management System (QMS)?

A Quality Management System (QMS) is a structured framework implemented by organizations to ensure consistent quality in their products or services. It encompasses a set of processes, procedures, policies, and documentation that outline the methods and practices required to meet customer expectations, regulatory requirements, and industry standards. A well-designed QMS aims to enhance efficiency, minimize errors, and foster continuous improvement throughout the organization’s operations. By monitoring and controlling various aspects of production, delivery, and customer interactions, a QMS contributes to the overall reliability, safety, and satisfaction associated with the organization’s offerings.

How does ISO 13485:20106 QMS work?

ISO 13485:2016 operates as a comprehensive framework for the establishment of a Quality Management System (QMS) tailored to the unique demands of the medical device industry. This standard orchestrates the orchestration of processes that underpin the entire product lifecycle, encompassing design, development, production, distribution, and post-market activities. By fostering a meticulous integration of risk management principles and design controls, ISO 13485:2016 ensures that organizations identify, evaluate, and mitigate potential risks while meticulously aligning their product designs with intended functionality and regulatory prerequisites. Additionally, the standard emphasizes effective supplier management to guarantee the integrity of components and materials, all while upholding the critical aspects of quality, safety, and compliance that define the medical device landscape.

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Nectar is an award-winning design & engineering consultancy with a specialization in medical device development. We are proudly 13485 certified, we adhere to the highest industry standards. Nectar has been an industry leader in Southern California for over 25 years. Our proven user-centered design process has facilitated the successful launch of hundreds of products in the market.
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    What are the Key Regulatory Requirements in Medical Device Design and Development?

    The key regulatory requirements for medical device design and development are outlined in ISO 13485:2016 and FDA 21 CFR part 820.32 (c). These standards lay out essential principles, including documentation of design stages, review requirements at each stage, verification and validation activities, allocation of responsibilities, traceability from inputs to outputs, and allocation of necessary resources.

    What Specific Mandates are Covered in ISO 13485:2016 - Section 7.3.2?

    ISO 13485:2016, Section 7.3.2, focuses on design and development mandates within quality management systems for the market. It includes documentation of design stages, review specifications, verification and validation definitions, allocation of responsibilities, traceability methods, and determination of necessary resources. This section provides crucial guidelines for maintaining compliance and quality during the design and development of medical devices.

    Why is Integrating Risk Management into the Design Plan Important According to ISO 13485:2016 and 21 CFR Part 820.30?

    Integrating risk management into the design and development plan is crucial to ensure the safety and effectiveness of medical devices. Both ISO 13485:2016 and FDA 21 CFR Part 820.30 emphasize this integration to manage potential risks associated with the device’s design, development, and use. This involves careful consideration of potential hazards and mitigation strategies throughout the development process.










    An example of a risk matrix with probability and severity as the X and Y axis of the graph.

    What Expertise Does Nectar Offer in Navigating the Complexities of Medical Device Development?

    With an ISO 13485:2016 certified Quality Management System, Nectar provides more than just a certification badge. Their expertise spans compliance with regulatory standards, intricate knowledge of the design and development process, and a track record of innovation. Nectar’s experience positions them as a valuable guide for navigating the complexities of medical device development.

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    We are an ISO 13485-certified design and engineering firm based in Southern California, specializing in the development of cutting-edge medical devices.

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