Welcoming the New Year with New Possibilities
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 2024! How are those New Year's resolutions going...?
Ours are going well so far - we've committed to providing even better service and expertise to our clients this year.
As we enter this new year, the LFH Regulatory team is as dedicated as ever to working with you to build a regulatory framework that meets all compliance requirements. We know how challenging and complex regulatory compliance can be, especially with frequently changing regulations across global markets. But that's what we're here for - to simplify the process so you can bring your innovative products to market quickly and effectively.
Our expertise spans all medical devices, including in-vitro diagnostics, software as a medical device, combination products and more. We stay on top of the latest regulations and guidelines so you can focus on what you do best - developing cutting-edge medical technologies.
2023 was a great year for LFH Regulatory, and 2024 is set to be even better. We have some exciting plans in the works to expand our services and help more MedTech companies achieve regulatory compliance.
So, if 2024 is your year to launch a new product or expand into new markets, come to LFH Regulatory for tailored guidance every step of the way!
We're ready to make 2024 your most successful year yet, are you?
New Blog
Get Guidance on Creating an ISO 13485 Quality Manual
Are you looking to implement a quality management system in your organisation?
Our new blog provides useful tips and information on developing a quality manual that meets ISO 13485 requirements.
Learn what sections to include, which clauses may be deemed non-applicable, and see an example format for structuring your manual.
Whether you're creating a quality manual from scratch or updating an existing one, our article can help ensure your documentation aligns with ISO 13485 and your QMS.
Read the full blog by clicking the button below.
MHRA
Regulatory Framework Roadmap
This month, the MHRA published their roadmap towards the future regulatory framework for medical devices in the UK. This is an important step in shaping regulations to ensure patient safety remains the top priority as the industry continues to innovate.
The new regulations aim to modernise the processes for medical device compliance in the UK market.
They will put patient safety first and help to ensure that patients continue to have access without delay to the devices they need whilst enhancing the UK's position as a world-leading environment for medical technology innovators.
For medical device manufacturers, these changes could impact timelines for product launches and post-market surveillance requirements. At LFH Regulatory, our team of experts are already analysing the implications of the MHRA's roadmap, and we are ready to provide guidance on new compliance requirements and strategies to smoothly transition to the evolved regulatory framework!
Quality Management System
Have you got a comprehensive QMS system?
At LFH Regulatory, quality, safety and compliance are paramount. That’s why a robust, optimised Quality Management System (QMS) is critical.
Our Quality Management Review Pathway offers a comprehensive analysis of your current QMS to identify any gaps, inefficiencies or potential non-conformances.
We thoroughly assess all aspects of your quality system to ensure alignment with the latest regulatory standards.
Then, we work with you to implement customised solutions - restructuring processes, integrating software, training staff and more. The focus is structuring your QMS to maximise compliance, productivity and patient safety.
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With our support, you can swiftly adapt to changing regulations, speed up product launches, and continuously improve quality.
AI-Driven Expertise
Simplifying SaMD Regulatory Compliance
AI is becoming more and more useful, and we don’t see this progress hindering any time soon in 2024.
Using advanced AI-driven platforms, we can streamline regulatory compliance for Software as a Medical Device (SaMD) companies. The technology assists experts in guiding clients through critical phases of development and regulatory compliance, ensuring alignment with international standards.
AI-driven solutions are integral to facilitating global regulatory compliance, offering vital support that could change the world of medical device compliance over the next few years. The systems enable proactive monitoring and rapid adaptation to the ever-evolving regulations across markets.
Medical Device Consultancy
Why Choose Us for Medical Device Consultancy?
Of course, we’re going to say that choosing LFH Regulatory is the best decision you can make in your journey of bringing your medical device to market, but what do we have to prove that this is true?
At LFH Regulatory, we are the leading UK-based Medical Device Regulation consultancy, dedicated to simplifying compliance complexities for approximately 500,000 types of medical devices and in vitro diagnostics registered in Europe.
Our seasoned consultants address changing regulations, ensuring your products meet compliance needs. But how? Take a look for yourself:
Our adept consultants offer tailored services to facilitate your regulatory requirements throughout the device lifecycle - from early testing to launch and ongoing management. Our services include:
Regulatory strategy: As a leading consultancy, our regulatory strategy acts as a compass for new product and design initiatives. It identifies key components and proactive solutions, anticipating issues and mapping a compliant roadmap.
Risk management: Comprehensive risk management is vital in the device lifecycle. We assist in drafting risk management files, identifying hazards, recommending mitigation strategies and ensuring ongoing safety.
Technical documentation: We play a key role in creating, updating and remediating your technical files to evidence consistent compliance and safety.
Person Responsible for Regulatory Compliance (PRRC): Our consultants possess the expertise to support your organisation in fulfilling PRRC responsibilities under Article 15 of the Medical Device Regulation 2017/745.
With decades of experience, trust LFH Regulatory to steer your medical device through evolving global regulations.
What will 2024 Bring for LFH Regulatory?
Looking at the Year Ahead
2023 was a successful year for LFH Regulatory as we helped numerous clients achieve regulatory compliance and bring life-changing technologies to market.
Now, we look ahead to 2024 - it is set to be an exciting year as we expand our services and partnerships to enable more MedTech innovation.
If you are planning a new product launch, expansion into new markets, or have any regulatory needs - get in touch.
Together, we can shape the future of healthcare through regulatory excellence.