RA Design & Development

Embark on your journey by conceptualizing your IVD or MD. Our team of specialists will guide you through the design and development process, ensuring that your product meets the highest standards of quality and safety.

Whether you are beginning the process or are an established manufacturer requiring assistance with evaluating design changes and how these impact your regulatory submissions, we can help you identify the optimal solution.

What is design & development?

Design and development is the foundation for bringing innovative and compliant medical devices (MDs) and in vitro diagnostic devices (IVDs) to market. It encompasses the entire lifecycle of a product, from initial concept to final validation, ensuring that the product is safe, effective, and meets all regulatory requirements.

This process includes defining the intended purpose, designing and testing prototypes, compiling technical documentation, and conducting clinical or performance evaluations. The goal is to build a high-quality product that not only fulfills its intended use but also complies with the applicable regulations, such as the EU MDR or IVDR.

While the overall approach shares similarities, specific regulatory requirements and methodologies differ for IVDs and MDs. Below, we’ve outlined these distinctions to ensure clarity and focus for your product’s needs.

→ Design & Development for Medical Devices

→ Design & Development for In Vitro Diagnostics

Design & Development for Medical Devices

For medical devices, the design and development process ensures the safety, effectiveness, and compliance of devices used for therapeutic or diagnostic purposes. Key aspects include:

Intended Purpose Statements & Classification:

Defining your product’s intended purpose and classification is vital to compliance with MDR. Our team will ensure your product is accurately classified, and help select the best conformity assessment route for obtaining CE certification or performing CE self-certification.
Clinical Evaluation Documentation:
MDR requires robust clinical evaluation to demonstrate safety and performance. This includes:
- Literature study.
- Clinical evaluation plan and report.
- Post-market clinical follow-up (PMCF) plans and reports.
- Clinical trials if necessary.

QbD Group offers a full CRO service, we can assist you with complete or partial Clinical evaluation documentation.

Design & Development - Regulatory Affairs - QbD Group

Design & Development for In Vitro Diagnostics

For IVDs, the design and development process is focused on the performance evaluation of diagnostic tools to ensure they deliver reliable and accurate results. Key aspects include:

Intended Purpose Statements & Classification:
Defining your product’s intended purpose and determining its correct IVDR classification are critical steps. Our experts will assess your device, ensuring it aligns with IVDR requirements, and guide you in selecting the appropriate conformity assessment route.
Performance Evaluation Documentation:
Under the IVDR, performance evaluation consists of three essential components:
- Scientific Validity Report: Establishing the link between a biomarker and a clinical condition.
- Clinical Performance Studies: Demonstrating the device’s performance in real-world settings.
- Analytical Performance Studies: Assessing accuracy, precision, and reproducibility.

QbD Group can assist you with complete or partial Performance Evaluation Documentation.

Design & Development - Regulatory Affairs - QbD Group (1)

How we can support

Streamline your design & development process

Implement robust design control processes tailored to your product lifecycle.
Assess the impact of design changes on regulatory submissions and compliance.

Guide you through regulatory requirements with confidence

Identify and apply relevant regulations, standards, and common specifications for your product.
Resolve classification issues and define an IVDR-compliant or MDR-compliant intended purpose.
Transition seamlessly from IVDD to IVDR or from AIMDD/MDD to MDR compliance.

Achieve CE marking success

Build a customized roadmap to CE-marking, ensuring every step is efficient and compliant.

Optimize your technical documentation

Conduct a gap assessment of your existing technical documentation.
Assist in writing and composing comprehensive technical documentation that meets regulatory expectations.

Streamline your process

Guide you through regulatory requirements

Achieve CE marking success

Optimize technical documentation

Why partner with QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS

Tailored expertise and full life cycle support: With over 10 years of experience, QbD Group offers unparalleled expertise in regulatory affairs. Our team of highly qualified consultants provides support throughout the entire product life cycle—from pre-market development to post-market surveillance—ensuring your product meets regulatory standards at every stage.

Global reach, local expertise: With offices across Europe and South America, QbD Group operates on a global scale, enabling us to manage regulatory challenges in diverse regions and efficiently execute projects worldwide.

Customer-centric approach: At QbD Group, we prioritize your needs. We offer transparent communication, clear objectives, and continuous evaluation to ensure your satisfaction and success. Whether you're an established company or a startup, we work collaboratively with you to achieve your goals.