Expert Regulatory Guidance for Your Innovative Medical Devices
Laura Friedl-Hirst
Managing Director @ LFH Regulatory Limited | Regulatory Affairs I Quality Assurance I Clinical Affairs I UKCA & CE Marking I FDA I QMS I ISO 13485 I Global Registrations
Hi
Welcome to our October newsletter! Read on for updates on our recent team building, insights into medical device regulations, and details on our upcoming appearance at MEDICA.
But first, let’s start with our team-building day.
Last month, we held an insightful session focused on collaborating more effectively as a team. After looking back at our achievements from the past quarter and setting future goals, we headed over to Cave Escape and prepared to battle.
Starting Your MedTech Journey? We Can Guide You
Leverage Our Regulatory Expertise
Bringing a medical device to the market involves adhering to complex regulations. From clinical evaluations to technical documentation, ensuring compliance on your own can be challenging. That's where we come in.
With deep expertise across quality, compliance and regulatory requirements, LFH Regulatory Limited is your partner in navigating regulations. We handle everything from:
Our specialised team has the knowledge and experience to steer you smoothly through the complex regulatory environment, allowing you to stay focused on your innovative product.
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IEC 62304 Essentials
Meeting Critical Safety Standards
Medical device software must meet rigorous safety and effectiveness standards. That's where IEC 62304 comes in. This globally recognised standard outlines critical processes for safe software design and maintenance with a medical purpose.
IEC 62304 key facts
Let us help assess your software against IEC 62304. Our expertise can identify gaps and guide you to compliance, ensuring your software meets the highest safety and quality standards.
Upcoming Event
MEDICA 2023
Join us at Medica 2023 in Düsseldorf!
We're thrilled to announce that we'll be exhibiting in hall 16. K48-3 at Medica 2023, taking place November 13-16 in Düsseldorf, Germany. As the world's largest medical trade fair, Medica is the premier event for medical technology companies.
Our team of regulatory experts will be on hand to provide advice on navigating regulations and getting your medical devices to market efficiently. Additionally, our Founder and Director Laura Friedl-Hirst will give a presentation in the conference area, offering key insights and strategies for remaining compliant.
Will we see you in Düsseldorf? Click the button below to book a chat with LFH Regulatory Limited director.