Design & Development

Design & Development For Medical Devices, Done Right

With our scientific and regulatory expertise at MEDRA, we understand the intricacies of product development, from initial concept to final launch. We prioritize collaboration and innovation, ensuring that each product not only meets regulatory standards but also resonates with market needs. We guide our clients through each phase of development, minimizing risks and optimizing outcomes.

Additionally, we offer tailored solutions that cater to specific industry requirements, Medical Devices and IVD, Combination Devices and Digital Health (AI). Our expertise in regulatory affairs ensures that our clients navigate the complex landscape of compliance with ease, allowing them to focus on what they do best-creating exceptional products.

What We Do: Comprehensive Design & Development Support

MEDRA offers specialized support across the process of design & development lifecycle, from clinical evidence design plan, design input and design output to benefit-risk analysis, design validation, design verification, design transfer and usability study. Our services are aligned with EU MDR 2017/745, FDA and other global regulatory requirement to age and effective design.

Speed Up Your Medical Device Development

As a flexible partner with your team, we offer a variety of services from immediate assistance to full scale development
Transform your vision into reality, delivering innovative solutions that stand out in a competitive marketplace.

Deliver Comprehensive Support

From initial idea to final production, we function as an integral part of your team, assisting you as every stage of the development process.

Minimize Risks

Benefit-risk analysis and conclusions
Incorporating applicable quality and regulatory standards at each stage of design.

Human Engineering Factors & Design Optimisation

We ensure that your device is not only innovative but also account for all human factor engineering for safe and effective use.

Design Changes Control

Any modifications to the design must be managed through a formal change control process. Significant alterations should be evaluated for their potential effects on the device’s regulatory compliance, safety, and performance. All changes must undergo verification and validation before they are implemented.

Regulatory & Lifecycle Support

Act as a single point for product development from concept to safe approved product on the global market.
Ongoing regulatory support across the device lifecycle when design change or regulatory update occurs.

How We Work

Our Proven 6-Step Design & Development Workflow

We deliver efficient, compliant design & development through a transparent, collaborative process.

1

Design Planning

The cornerstone of the development process is a thorough Design and Development Plan. This essential document delineates the project’s scope, objectives, and expected deliverables, encompassing:

– Clear project objectives and scope
– Stages of design and development (including inputs, outputs, verification & validation, and design transfer)
– Assigned responsibilities for the development team members
– Compliance with regulatory requirements for target markets
– Risk management strategies
– Criteria for supplier selection and management

A well-defined plan is crucial for ensuring that all team members are aligned with the project’s objectives, facilitating both quality and timely outcomes.

2

Design Inputs

Design inputs represent the physical and performance criteria that establish how the device will function. These inputs should be informed by customer needs, user expectations, and necessary regulatory guidelines, while also aligning with the device’s intended use.

Essential components of design inputs include:

– User requirements and expectations
– Safety and regulatory obligations
– Performance specifications for the product
– Usability standards
– Market-specific criteria for device classification

3

Design Outputs

Design outputs consist of the documented results stemming from the design process, which are usually compiled in a Design Traceability Matrix. These outputs encompass:

– Product specifications
– Specifications for raw materials, components, and subassemblies
– Packaging and labeling guidelines
– Design drawings, schematics, and manufacturing instructions
– Regulatory documentation for market approval
– Risk management reports and validation documentation in accordance with ISO 14971

These outputs serve to illustrate that the design and development processes are in alignment with the original requirements.

4

Design Verification and Validation

Verification and validation are essential processes that guarantee the device fulfills its established input requirements.

– Verification involves confirming that the design adheres to the specified requirements.
– Validation ensures that the device aligns with user needs and its intended application.

The documentation for verification and validation may comprise various elements such as test protocols, clinical evaluation records, performance assessment data, and, if applicable, information from clinical trials.

5

Design Transfer

After successfully completing all verification and validation tests, the design is ready to be transferred to the manufacturing phase. This stage encompasses:

⁠Final approval of the design
Preparation of production documentation
Detailed manufacturing instructions
⁠Quality control plans

It is vital that design transfer documentation is clear and thorough to streamline the manufacturing process and maintain product consistency.

6

Design Review

Design reviews, often referred to as ‘stage-gate meetings’, serve to verify that each phase of the design process has been completed satisfactorily before advancing to the next stage. These reviews should be conducted at predetermined intervals throughout the design journey, with minutes documented for reference. For instance, a review is held to confirm that the design inputs are both adequate and relevant to the device before progressing to the development of design outputs.

Design & Development