ISO Compliance Guidelines and Design Controls for Medical Devices

Imagine facing a recall that costs your company up to $600 million—sounds catastrophic, right? According to McKinsey, that’s the reality for some manufacturers, with the medical device industry losing up to $5 billion annually to recalls. This is where medical device design and ISO compliance come into play. 

Design controls, mandated by standards like ISO 13485 and ISO 14971, are the foundation of safe and effective product development. These structured processes ensure devices meet user needs, regulatory requirements, and safety standards while minimizing risks and avoiding costly errors. In this blog, we’ll break down the essentials of design controls and explain how adhering to medical device design and ISO compliance can set your products apart.

What Are Medical Devices Design Controls? 

Design controls are structured processes that medical device manufacturers use to ensure their products meet user needs, regulatory standards, and safety requirements. These controls are not optional; various global regulations and standards, including ISO 13485, mandate them. By systematically managing every phase of product development, design controls create a traceable framework for accountability and quality.

What is the Purpose of Design Control?

The primary purpose of design controls is to minimize risks and ensure that medical devices perform as intended. They help manufacturers:

1. Align with User Needs: By defining clear design inputs, manufacturers can ensure the device addresses real-world problems.
2. Ensure Safety and Compliance: Design controls incorporate risk management, verification, and validation to guarantee safety.
3. Maintain Traceability: Each step of the development process links back to documented requirements, ensuring transparency.
4. Streamline Market Approval: Regulators and auditors review design history files to assess compliance, speeding up approvals.

Effective design controls reduce the likelihood of errors, recalls, and regulatory penalties while fostering trust with users and stakeholders. Some ISO standards actively provide a comprehensive framework for implementing and managing design controls to achieve these objectives. They are as follows.

Different ISO Compliances That Defines Medical Devices Design Controls

The ISO standards that collectively define the framework for design controls, ensuring devices are safe, effective, and compliant with global regulations are:

1. ISO 13485:2016: Focuses on quality management systems for medical devices. It requires manufacturers to establish and maintain design and development processes.
2. ISO 14971: Mandates risk management throughout the product lifecycle, emphasizing the identification, evaluation, and control of risks.
3. ISO/TR 24971: Offers technical guidance on implementing ISO 14971, providing additional clarity for risk management.
4. ISO 62366: Ensures usability engineering is integrated into design controls, improving user safety and effectiveness.

Let’s explore how these ISO standards define design control in detail.

Key ISO Standards Shaping Medical Device Design Controls

Achieving success in medical device design and ISO compliance requires a deep understanding of the global standards that govern the industry. Each standard highlights specific requirements for design controls, ensuring that medical devices meet user needs while adhering to regulatory expectations. Below, we explore the key ISO compliances and how they shape medical device design.

1. ISO 13485:2016 – Quality Management Systems for Medical Devices

One of the most widely used international standards for quality management in the medical device industry is ISO 13485:2016. ISO 13485 serves as the foundation for medical device design and ISO compliance by defining the requirements for a Quality Management System (QMS). It focuses on maintaining quality throughout the design and development lifecycle.

Design Control Highlights:

• Documented Processes: Manufacturers must establish procedures for managing design inputs, outputs, verification, validation, reviews, and changes.

Effortlessly manage ISO 13485 compliance with BPRHub’s Document Hub, centralizing SOPs, quality manuals, and audit reports for seamless compliance.

• Risk-Based Approach: Incorporates risk management throughout the design process to proactively address potential safety concerns.
• Design History File (DHF): Requires detailed documentation of all design activities, ensuring full traceability.

2. ISO 14971:2019 – Risk Management for Medical Devices

Risk management is critical for device safety, and ISO 14971 provides a structured approach to identifying, evaluating, and mitigating risks throughout the device's lifecycle.

Key Requirements:

• Hazard Identification: Anticipates risks, including potential misuse of the device.
• Risk Control: Mandates safety features like alarms and fail-safes to minimize risk.
• Residual Risk Evaluation: Ensures any remaining risks are acceptable before the device is released.
• Post-Market Monitoring: Requires ongoing surveillance to catch emerging risks.

3. ISO 62366:2015 – Usability Engineering for Medical Devices

ISO 62366 focuses on designing medical devices that are easy and intuitive for users, reducing the likelihood of errors and enhancing patient safety.

Key Requirements:

• User-Centered Inputs: Incorporates user needs, environmental factors, and skill levels into design specifications.
• Usability Testing: Encourages iterative testing to identify and fix interface challenges early.
• Error Mitigation: Aims to reduce errors caused by unclear instructions or complex designs.

Regular auditing is key to mitigating errors.

 BPRHub’s Audit Hub enables seamless tracking of usability testing, error analysis, and compliance checks, ensuring your medical devices meet ISO standards while enhancing safety and user satisfaction.

4. ISO/TR 24971:2020 – Technical Guidance on Risk Management

ISO/TR 24971 complements ISO 14971 by offering detailed guidance on implementing effective risk management processes in real-world scenarios. Interestingly, this standard bridges the gap between theoretical risk management and practical implementation, enhancing the effectiveness of design controls.

Key Requirements:

• Expanded Risk Evaluation: Provides advanced techniques to assess and prioritize risks.
• Real-World Case Studies: Demonstrates practical applications to help manufacturers navigate complex scenarios.
• Seamless Integration: To ensure consistency, integrate risk management processes with design controls.

To maintain multiple ISO standards for medical device design control, get a free consultation with BPRHub’s Standard Hub, which offers a unified, user-friendly platform to manage multiple compliance. 

Building on the ISO standards and understanding the specific design controls are essential for ensuring compliance, safety, and efficiency. Let’s learn the key design controls that form the foundation of successful medical device development.

Understanding Key Design Controls

Design controls are the backbone of medical device design and ISO compliance, ensuring a systematic, traceable process for developing safe and effective devices. Let’s break down each design control to understand its purpose and role in achieving compliance.

1. Design and Development Planning

This initial phase involves creating a clear roadmap for the entire design and development process. The plan outlines responsibilities, resources, timelines, and milestones.

• Purpose: Establish structure and accountability for design activities.
• ISO Relevance: ISO 13485 mandates that manufacturers maintain documented plans to ensure design processes are controlled.

2. Design Inputs

Design inputs define the device’s requirements based on user needs, regulatory standards, and risk assessments. These inputs include functional, performance, and safety specifications.

• Purpose: Translate user and regulatory needs into actionable design requirements.
• ISO Relevance: ISO 13485 and ISO 14971 emphasize using inputs as a foundation for risk management and compliance.

3. Design Outputs

Design outputs are the tangible results of the design process, such as schematics, manufacturing instructions, and software code. They must align with the requirements established in the design inputs.

• Purpose: Provide a detailed blueprint for production and testing.
• ISO Relevance: Outputs must be documented and verified to ensure compliance with ISO standards.

4. Design Reviews

Periodic design reviews involve evaluating the progress of the design process to identify issues early and ensure alignment with requirements.

• Purpose: Validate design direction and identify potential problems proactively.
• ISO Relevance: ISO 13485 requires formal reviews at critical milestones for accountability and traceability.

5. Design Verification

Verification confirms that the design outputs meet the design inputs. This phase involves testing, inspections, and analyses.

• Purpose: Ensure that the design accurately reflects the specified requirements.
• ISO Relevance: Verification activities are crucial for demonstrating compliance with ISO 13485 and ISO 62366.

6. Design Validation

Validation ensures that the finished device performs as intended in real-world conditions. It involves usability testing, clinical trials, and feedback from end-users.

• Purpose: Confirm that the device meets user needs and performs safely and effectively.
• ISO Relevance: ISO 13485 and ISO 62366 emphasize validation to address usability and safety concerns.

7. Design Transfer

Design transfer focuses on converting design outputs into production specifications. This step ensures the device can be manufactured consistently and at scale.

• Purpose: Facilitate a seamless transition from development to production.
• ISO Relevance: ISO 13485 mandates proper documentation and validation of transfer processes.

8. Design Changes

Design changes involve modifying the device or its specifications after the initial design is complete. This process must be carefully managed to maintain compliance.

• Purpose: Address issues or improvements without compromising safety or compliance.
• ISO Relevance: ISO 13485 requires all changes to be documented, reviewed, and validated.

9. Design History File (DHF)

The DHF is a comprehensive record of the entire design process. It includes documentation of all activities, reviews, and decisions made during development.

• Purpose: Provide traceability and evidence of compliance with design controls.
• ISO Relevance: ISO 13485 mandates maintaining a DHF to support regulatory submissions and audits.

Implementing effective design controls demands precision and efficiency. BPRHub equips manufacturers with the essential tools to simplify compliance processes. Below is a detailed explanation.

How does BPRHub Facilitate Medical Device Design Control and ISO compliance?

Ensuring compliance with global standards like ISO 13485, ISO 14971, and ISO 62366 can be challenging for medical device manufacturers. From managing design inputs to documenting risk assessments, each step in the process requires precision and efficiency. This is where BPRHub steps in as a transformative solution to streamline medical device design control and ISO compliances.

BPRHub is a comprehensive platform tailored for medical device manufacturers. It helps them meet regulatory standards, reduce manual errors, and improve efficiency. It streamlines compliance with ISO 13485, ISO 14971, and ISO 62366 through features like automated document control, risk assessment tools, and usability engineering support. It offers process-ready documents for ISO 9001, real-time updates, and tools to optimize production, automate design controls, and maintain audit-ready DHFs, ensuring manufacturers stay compliant and efficient.

With BPRHub, streamline your medical device design control and ISO compliance. Automate documentation, manage risks, and ensure usability while maintaining audit-ready records.

FAQ’S

1. Which ISO standards are critical for compliance with medical device design control?
Ans: Key ISO standards include ISO 13485 for quality management, ISO 14971 for risk management, ISO 62366 for usability engineering, and ISO/TR 24971 for risk management guidance. Together, they ensure safe and compliant device development.

2. How does BPRHub help streamline medical device design control and ISO compliance?
Ans: BPRHub automates documentation, integrates risk management tools, and supports usability testing, making it easier for manufacturers to meet ISO standards like 13485 and 14971 while maintaining audit-ready records.

3. What are design controls in medical devices?

Ans: Design controls in medical devices are systematic processes mandated by regulations like ISO 13485 to ensure devices meet user needs, safety standards, and regulatory requirements. They involve planning, verification, validation, and documentation to ensure quality, safety, and compliance.

4. What is the difference between ISO 13485 and 14971?

Ans: ISO 13485 is a standard for quality management systems specific to medical devices, focusing on regulatory requirements and ensuring product safety and effectiveness. ISO 14971, on the other hand, is a risk management standard for medical devices, outlining processes for identifying, evaluating, and controlling risks throughout the product lifecycle.

5. How does BPRHub’s Standard Hub support ISO compliance for medical devices?

Ans: BPRHub’s Standard Hub streamlines ISO compliance by centralizing SOPs, quality manuals, and design history files. It automates design controls, risk management, and verification processes, ensuring manufacturers meet ISO 13485 and ISO 14971 requirements efficiently and maintain traceability throughout the product lifecycle.