Struggling to Keep up With Medical Device Regulatory Affairs? We’ve Got You Covered
In the highly regulated world of Pharma, Diagnostics and MedTech, the regulatory landscape can be complex and demanding. Regulatory Affairs (RA) plays a critical role in this environment. Whether you are updating an existing product or creating a new medical device, strong medical device Regulatory Affairs support can make the difference between success and failure.
Our RA specialists help clients craft regulatory strategies, conduct gap assessments for FDA, MDR and IVDR compliance, classify medical devices and much more.
Our Capabilities
Whether your organization needs a single competence or the entire range, we are here to help you. Read more about our medical device Regulatory Affairs services:
Regulatory Strategies
Gap Assessment
Regulatory Intelligence
Device Classification
Submissions
Technical Documentation
RA Support
Notified Body Opinion
EUDAMED
Compliance is a Complex Challenge. We’re Here to Help You Navigate it Together.
Regulatory Affairs is key to ensure the regulatory compliance of Pharma, Diagnostics and MedTech companies when bringing new products to market. This is no easy feat for many organizations.
Our team of regulatory specialists often find clients confused by the sheer number of regulatory requirements and how to interpret them. Which risk class does our combination product belong to? How do we facilitate a smooth process when communicating with and answering questions from notified bodies? What are the strategies for getting our medical device ready for approval in different markets?
These are some of the questions that we have the knowledge and skills to help answer based on real-world experience from countless medical development projects. We are experts in advising and assisting clients from project ideation to product launch. We know how to apply Regulatory Affairs practices at every stage of development.
Every year brings new medical device requirements, along with changes to existing ones across the world of Pharma, Diagnostics and MedTech. These constant updates make it hard for teams to keep up and understand how the changes may affect their products. A recent example could be the MDR / IVDR Transition. Our Regulatory Affairs specialists can help your organization run the gap assessments needed to make sure your products meet FDA, MDR and IVDR requirements.
Failing to classify a medical device correctly is a common mistake. If a team is not careful, they may miss required submission deadlines. Being too cautious when assessing risk can also create far more documentation work than needed. Navigating the complex world of Medical Device Regulatory Affairs requires both deep knowledge and broad experience from the healthcare industry.
Our Regulatory Affairs consultants possess both, which ensures that our sharp focus on meeting regulatory requirements will go hand in hand with our clients’ needs for creating business value and bringing products to market. When getting our regulatory affairs specialists on board your team, you get much more than RA skills. At MGS, we are a focused team of nerdy specialists in areas like Mechanical Engineering, Project Management and Design Control. WE take pride in sharing knowledge and supporting our colleagues and clients.
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Get in Touch
Looking for assistance with medical device regulations? Send us a message to connect with a Regulatory Affairs expert.
We Have the Expertise to Take You From A to Z
Whether you need a single competency or a combination of skills, our experts are ready to assist you through the entire development process. Based on the specific needs of the project, we assemble the ideal team of specialists.
We integrate advanced manufacturing knowledge into the earliest design phases and minimize the number of iterations. Our complete offering takes your project seamlessly through the entire value chain ensuring faster time-to-market combined with minimized risk.
Check out all our areas of early-stage design expertise.
Related Cases
Regulating Medical Devices in the European Union: Legislation vs. Driving Business Outcomes
Healthtech magazine article shines the spotlight on the challenges and rewards of building your business processes around regulatory compliance.
9 Product Families Submitted for Approval in Timely MDR Transition Project
Transitioning from MDD to MDR compliance touches on several different business processes – all happening within a strict deadline. Therefore Ambu A/S decided to initiate the process well in advance and team up with MGS.
