Design and Development Services

Bringing a medical device from concept to market requires a clear understanding of regulatory requirements, risk management principles, and robust design processes. Our design and development services support manufacturers throughout the entire product development lifecycle, ensuring that every step of the process complies with global regulatory standards. Whether you are working on a Class I, II, or III medical device, we provide the expertise needed to navigate complex regulatory environments and bring safe, effective products to market.

At the core of our services is a focus on integrating risk management principles early in the design process. We work with your team to develop comprehensive risk management files in compliance with ISO 14971, helping identify and mitigate potential risks from the outset. Our risk-based approach ensures that hazards are addressed during the design phase, reducing the likelihood of costly redesigns or post-market issues. We also conduct thorough design reviews to ensure that all design inputs meet the intended use and regulatory expectations.

Our team assists with the development of design controls, which are essential for regulatory compliance, especially under the FDA’s design control requirements and the EU MDR. These controls ensure that design changes are appropriately documented, reviewed, and verified. From design verification to validation, we help ensure that your device meets regulatory expectations and performs as intended.

We also provide support with technical documentation, ensuring that all regulatory submissions are complete and accurate. Whether you're preparing for a 510(k) submission, a CE mark application, or a pre-market approval (PMA) submission, we assist with compiling the necessary design history files, risk management files, and other technical documents required by regulatory authorities. Our team helps streamline the process, reducing the risk of delays and increasing the likelihood of a successful submission.

Our design and development services include:

• Risk Management System according to ISO 14971: Implement and maintain a risk management system that integrates with your quality management system (QMS) to meet global regulatory standards.
• Developing the Quality Manual: Create and develop a compliant quality manual that aligns with ISO and FDA requirements.
• Risk Communication: Establish clear communication of risks throughout the lifecycle of the device, ensuring transparency and compliance with regulatory expectations.
• Risk Lifecycle and QMS Integration: Seamlessly integrate risk management throughout the device lifecycle and within your QMS.
• Cybersecurity & Privacy: Ensure your device is secure by addressing cybersecurity risks and maintaining patient privacy standards, especially for connected devices.
• QMS Development and Improvement: Build or enhance your quality management system to meet international regulatory standards, ensuring long-term compliance.
• Design and Development Planning and Processes: Establish structured processes for design planning, ensuring smooth and efficient project execution.
• Design Reviews: Conduct formal design reviews to assess the progress and compliance of your product during its development stage.
• Verification and Validation: Perform thorough verification and validation activities to confirm that the product design meets regulatory and functional requirements.
• Device Master Record (DMR): Create and maintain a comprehensive DMR that documents the necessary production details and procedures for your device.
• Design History File (DHF): Ensure your DHF is complete and compliant with FDA and ISO 13485 requirements, documenting the design process and changes.
• Change Control process: Manage and document all design and process changes throughout the product lifecycle, ensuring compliance with regulatory requirements.
• Supplier and Sub-Contractor Evaluation: Evaluate and monitor suppliers and sub-contractors to ensure they meet the necessary quality and regulatory standards.
• CAPA Governance Structure: Develop a robust corrective and preventive action (CAPA) governance structure to manage and resolve issues.
• CAPA System Development, Gap Assessment, and Best Practices: Build an effective CAPA system, conduct gap assessments, and apply best practices to continually improve your processes.
• Claims and labeling review

In addition to regulatory compliance, our design and development services also focus on usability engineering and human factors. We help manufacturers design devices that are not only compliant but also user-friendly and intuitive. By incorporating usability testing into the development process, we ensure that your device meets the needs of both healthcare providers and patients, reducing the risk of use errors.

From early-stage development to final design transfer, we provide comprehensive support to ensure your product is ready for market launch. Our global expertise in regulatory compliance and product development allows us to help you meet the requirements of multiple regions, bringing safe and effective medical devices to market efficiently.

We have compiled a list of articles and training courses on the issue of design and development to help you and your colleagues.

Design Controls for Medical Devices and IVDs
In addition to providing an in-depth discussion of contemporary design and development principles and practices (and corresponding EU and FDA regulatory requirements), this approximately four-hour, self-paced course explores the essential relationships between risk management and design and development throughout the lifecycle of a medical device.

Mastering CAPA Effectiveness: A Comprehensive Step-by-Step Guide
Have you ever reviewed an investigation report and wondered if the proposed corrective and preventive action (CAPA) would be effective? This article considers how you can understand the effectiveness of CAPAs and introduces the NSF CAPA Hierarchy.

Deviation Investigations and CAPA
Our Deviation Investigations and CAPA eLearning is a 30-minute introductory course that provides an overview of the requirements of a deviation investigation and CAPA process. It outlines the key features of the system as well as the life cycle of the deviation investigation steps.