LFH Regulatory Limited

Exciting Funding Opportunity for UK MedTech Companies! 🚀   We’re thrilled to announce that the Office for Life Sciences is offering grant funding of up to £30,000 to support small and medium-sized enterprises (SMEs) navigating the complexities of medical device regulations. This programme is designed to help you access vital regulatory affairs advice from third-party specialists, ensuring you can meet evolving regulatory requirements.   Key Details: ✅ Funding Amount: Up to £30,000 per company ✅ Application Period: Opens on 9th October 2024 and closes at midday on 31st October 2024. It’s first come, first served, so apply early! ✅ Eligibility: Only regulatory affairs support is eligible for reimbursement; technical R&D and equipment/software purchases are not included. ✅ Application Process: Submit your application via Microsoft Form. A maximum of 300 applications will be reviewed, and funding will be awarded based on eligibility and scoring criteria.   Important Notes: ✅ You must nominate a single UK-based regulatory affairs support provider for reimbursement. ✅ Ensure your provider is informed about this funding opportunity, as they may need to provide additional information.   👉 Find out more here: https://lnkd.in/exxPE--F   If you have any questions or need assistance with your application, please don’t hesitate to reach out. At LFH Regulatory Limited, we’re here to support you throughout the process!   #MedTech #FundingOpportunity #RegulatoryAffairs #SMEs #LFHRegulatory

Last week, the entire LFH Regulatory Limited team gathered in London for an incredible team-building event focused on enhancing our project management skills and client relations.   We looked into strategies for managing client expectations, exploring ways to be more efficient and effective as a business. Our commitment to customer satisfaction is unwavering; at LFH Regulatory Limited, we’re keen to ensure 100% satisfaction for our clients. We’re not just focused on compliance—we’re dedicated to creating a positive customer journey that leaves our clients happy and engaged.   Collaboration was key as we discussed how to better meet our clients' needs while fostering a culture of accountability, progression, and incentives within our team.   To top off the day, we put our skills to the test in an escape room challenge! It was a fantastic way to bond, think creatively, and showcase the power of teamwork. 💪 🗝️   A big thank you to everyone involved for making this event a success. Together, we’re not just building a better business; we’re building a stronger team!    #TeamBuilding #ProjectManagement #ClientSuccess #LFHRegulatory #RegulationMadeSimple

📢 Seeking an RA Consultant Fluent in Italian 🇮🇹 We are currently looking for a Regulatory Affairs (RA) Consultant for our client for a set project . The ideal candidate must be fluent in Italian (both written and spoken) and have a strong understanding of regulatory requirements within the industry. Key Qualifications: ✅ Native or fluent in Italian (written & spoken) ✅ Experience in Regulatory Affairs ✅ Knowledge of local and EU regulations ✅ Strong attention to detail and communication skills If you or someone you know fits this profile, please reach out to Laura Friedl-Hirst or Jessica Hambidge directly. #regulatoryaffairs #hiring #consultant #Project

We are excited to support Project Youth Cancer through the Project Dragon  campaign—a corporate initiative showcasing companies' commitment to the future of Project Youth Cancer and its vital work with teen and young adult cancer patients. It’s important to support a local Huddersfield charity that is making a difference across the country. 🐉Project Dragon invites companies to provide regular financial support, enabling the charity to fund essential research, hospital resources, and mental health counselling. This support empowers young people to thrive during and after treatment. By joining Project Dragon, companies can:  ⭐ Ensure ongoing funding for research and resources.  ⭐ Provide crucial mental health support.  ⭐ Engage staff in meaningful projects. 👉 Read the full article here - https://bit.ly/4gTi2zJ For more information on how your company can get involved, please visit Project Youth Cancer - https://lnkd.in/ewYYMGsS #LFHRegulatory #ProjectDragon #ProjectYouthCancer #CorporateSocialResponsibility #SupportYoungLives #Huddersfield #charity Pam Thornes Helen Mervill

Today (7th October), the Medical Device Coordination Group (MDCG) have been published MDCG 2024-12 new guidance on New Corrective and Preventive Actions (CAPA )Guidance for MDR2017/745 & IVDR 746/2017 Compliance regulations The guidance on Corrective and Preventive Actions (CAPA) for MDR & IVDR compliance covers CAPA Templates: 🔹 Annex I: Template for documenting CAPA plans 🔹 Annex II: Template for Joint Assessment Team review Link 👉 https://lnkd.in/d8EytXtM #MDCG #IVDR #MDR

Looking to build a robust Quality Management System (QMS) for your medical device business? 🌍 Discover how ISO 13485 can help ensure product safety, regulatory compliance, and customer trust in our latest blog, "Understanding ISO 13485: Building a Robust Quality Management System." Whether you’re streamlining your processes, managing risks, or navigating regulatory requirements, this article provides key insights to help you implement a strong and effective QMS. Read more here 👉 https://bit.ly/3zDBKPa #MedicalDevices #ISO13485 #QMS #RegulatoryCompliance #QualityManagement #RiskManagement #LFHRegulatory

Congratulations to Lyndon Boyer, our dedicated QA/RA Consultant, on his 1-year anniversary at LFH Regulatory Limited.    In his role, Lyndon has been instrumental in guiding our clients to successfully bring their medical devices and in vitro diagnostics (IVDs) to market—ensuring they stay compliant with industry standards. His expertise spans developing ISO 13485-compliant Quality Management Systems, preparing comprehensive technical documentation, conducting risk management activities, and steering clients through notified body audits and regulatory challenges.   What does Lyndon enjoy most about his work? "Being exposed to a variety of product types allows me to continually learn more about their regulation." Outside of work, Lyndon enjoys cooking, playing guitar, going to gigs, snowboarding, and weightlifting—an all-around impressive guy.   Here’s to many more successful years with us, Lyndon.   #anniversary #QA #RA #medtech #teamwork

🚨 EU IVDR - MDCG update 🚨 On 25th September, the Medical Device Coordination Group (MDCG) updated and released a comprehensive guideline about the application of transitional provisions for certification of Class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746. Link to source 👉 https://lnkd.in/gqBtBRWy #IVDR #Regulatorycompliance #MDCG

Helen George from LFH Regulatory Limited is delighted to be at the Medical Technology Ireland Expo and Conference – Europe's second largest and fastest-growing medical device design and manufacturing show! Taking place at Galway Racecourse, Helen will be walking the floors, meeting fantastic companies like STERIMED Infection Control, Test Labs - Medical Devices, ALBIS Distribution, Eyedea MedTech Education and Compounding Solutions! It's been wonderful to see Marianne Browning, Joanne Bell, Damian Carr and Mark Tibbetts. If you're attending and would like to connect, don’t hesitate to get in touch with Helen – she’d love to chat! #MedicalTechnologyIreland #MedTech #LFHRegulatory #MedicalDevices #Networking #GalwayRacecourse

LFH Regulatory Limited was delighted to attend the Project Youth Cancer Après Ski Event to help raise much-needed funds for the charity’s Christmas Appeal ✨🎄 Held at The Arches Dean Clough, this sold-out event brought early festive cheer to Halifax, with all proceeds dedicated to providing special Christmas gifts for young cancer patients spending the holidays in hospital. The evening, themed around the vibrant atmosphere of Aspen’s après ski scene, featured an outstanding performance by world-renowned saxophonist Ellie Sax 🎷, alongside energetic beats from DJ LBW that kept everyone on their feet. It was a privilege to support such a fantastic campaign and contribute to creating magical moments for young people facing cancer this Christmas. We also enjoyed sharing a table with fellow Huddersfield company Paxman Scalp Cooling—a true testament to community collaboration! Here’s to making a difference! #LFHRegulatory #ProjectYouthCancer #ChristmasAppeal #CommunitySupport #MakingADifference #FundraisingSuccess #ApresSkiEvent Pam Thornes Helen Mervill