Struggling to Keep up With Regulatory Affairs? We’ve Got You Covered
In the highly regulated world of Pharma, Diagnostics and MedTech, Regulatory Affairs (RA) is a make-and-break discipline when setting out to update existing products or develop new medical devices. 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 competency or the entire range, we are here to help you. Read more about our capabilities:
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 medical device belong to? How do we facilitate a smooth process when communicating with and answering questions from notified bodies? What are the strategies for getting the 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’ve been advising and assisting clients from project ideation to product launch and know how to apply regulatory affairs practices during every stage of the development process.
Every year brings new requirements and changes or additions to existing requirements to the world of MedTech and Pharma, making it challenging to keep up with and interpret the consequences. A recent example could be the MDR / IVDR Transition. Our Regulatory Affairs specialists can help your organization make the necessary gap assessments that will bring your product portfolio in compliance with the MDR/IVDR requirements.
Failing to correctly classify a medical device is another common pitfall for organizations. An inattentive approach may lead to failing to submit the device, while being too conservative when assessing the risks related to the device may result in an unnecessary documentation workload. Navigating the complex world of Regulatory Affairs requires both deep knowledge and broad experience from the healthcare industry.
Our Regulatory Affairs experts 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 tight-knit team of nerdy specialists within areas like Mechanical Engineering, Project Management and Design Control that are always keen to exchange knowledge and help out colleagues and their clients.
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Get in Touch
Looking for assistance with medical device regulations? Send us a message to connect with a Regulatory 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 seamless 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.
