RA Strategy for MD and IVD - Regulatory Affairs - QbD Group (2)

RA Strategy for Medical Devices and IVDs

Bringing your product to market requires more than just meeting legal requirements—it demands a strategic approach that minimizes risks, accelerates time to market, and ensures ongoing compliance. With constantly evolving regulations and an increasing focus on product safety and efficacy, it’s crucial to have a regulatory strategy tailored to your specific needs.

Our expertise in MD and IVD regulatory affairs allows us to guide you through each step of the process, from development to market access, offering solutions that align with your product's unique characteristics and intended use.

What is regulatory strategy?

A regulatory strategy is an essential framework that delineates the necessary steps and actions to effectively address the regulatory requirements for introducing a product, such as a Medical Device (MD) or In Vitro Diagnostic (IVD), to the market.

A well-developed regulatory strategy guarantees that a product adheres to all legal, safety, and performance standards, while also minimizing delays, costs, and risks. It encompasses a range of activities, from pre-market processes like clinical trials and product testing, to post-market surveillance and compliance, thereby providing a structured guide for achieving successful market entry.

Discover how we can support you.

How can we support

Tailored regulatory strategy

We’ll work closely with you to assist in developing a comprehensive regulatory strategy tailored to the specific IVD or MD product. This involves assessing regulatory requirements, identifying potential challenges, and formulating a plan for successful product registration and approval.

Regulatory liaison

Acting as intermediaries between your company and regulatory authorities, we’ll facilitate communication, respond to queries, and ensure a smooth interaction throughout the regulatory review process.

Risk management

We’ll guide you through identifying and assessing potential risks, helping to develop risk management plans and supporting documentation that meet all regulatory requirements.

Labeling and advertising compliance

Ensure that product labeling and advertising materials comply with regulatory requirements. This includes reviewing and advising on the content to ensure accuracy, clarity, and compliance

Post-Market Surveillance

Assist in developing and implementing post-market surveillance plans to monitor product performance and compliance after market release.

Incident reporting and corrective actions

In the event of serious incidents, we’ll help manage the reporting process and advise on corrective actions to address any compliance issues that arise.

Transition support

Whether you are transitioning from IVDD to IVDR or from MDD to MDR, we will provide expert guidance to ensure a smooth and efficient process, minimizing disruptions and keeping your product on track.

Training solutions

We offer tailored training programs designed to empower your team with the regulatory knowledge they need to stay ahead of compliance challenges.

Support for startups

For emerging companies, we provide dedicated support throughout the product development phase, helping you establish a solid regulatory foundation from the very beginning.

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.

Get in touch

RA Strategy for MD and IVD - Regulatory Affairs - QbD Group

Related content

Case study

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader

QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.

Whitepaper

Medical Device Regulation (MDR) Checklist

Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.

Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.

Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Technical Documentation Essentials for Medical Device Software

Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Webinar

Post-Market Surveillance Requirements for Medical Devices and IVDs

Learn about post-market surveillance requirements under MDR and IVDR regulations. Gain insights from industry experts in this on-demand webinar.

Whitepaper

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

Discover the key role of Regulatory Affairs in pharma and how Regulatory Affairs teams support product lifecycle management in this whitepaper. Download now.

Webinar

3D Printing in the Healthcare World

Explore the challenges and opportunities of 3D printing in healthcare, featuring expert insights on regulations, pitfalls, and efficiency.

Webinar

IVDR Extension Explained: Tips & Strategies

Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.

Whitepaper

Innovations in ATMP: state of the industry in 2024

This whitepaper explores the innovations in ATMP and solutions in detail, with a focus on the current landscape as of April 2024. Download now.

Case study

The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Webinar

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Learn about the Medical Device CE Certification Pathway, from classification to conformity assessment by a Notified Body. Join our webinar on demand.

Case study

Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.

Case study

Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.

Discover all

RA Strategy for Medical Devices and IVDs

What is regulatory strategy?

How we can support you

Tailored regulatory strategy

Regulatory liaison

Risk management

Labeling and advertising compliance

Post-Market Surveillance

Incident reporting and corrective actions

Transition support

Training solutions

Support for startups

Why partner with QbD Group?

Related content

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

Medical Device Regulation (MDR) Checklist

Regulatory Affairs for Pharma and Biotech

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

Drug-Device Combination Products and Article 117

Mobile health on the rise: exploring the regulatory landscape for reimbursement

Clinical investigations under MDR: key insights and practical experiences

CE Mark Renewal for bioXtra Products: A Success Story

Technical Documentation Essentials for Medical Device Software

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Post-Market Surveillance Requirements for Medical Devices and IVDs

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

3D Printing in the Healthcare World

IVDR Extension Explained: Tips & Strategies

Innovations in ATMP: state of the industry in 2024

The journey toward IVDR compliance for the LVOne device

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Helping Relu to comply with changing regulations

Quickly bringing a new COVID-19 medical device to market

Get in touch

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader