Internal auditing is a cornerstone of an effective QMS, especially in the medical device industry. But for audits to drive real value, independence isn’t just beneficial—it’s essential. In our latest blog, we explore 5 reasons why independence in internal auditing is not just beneficial but essential for medical device manufacturers. Read the full blog here to discover how embracing independence in your audit process can enhance your QMS and elevate your organization. https://lnkd.in/drefBiyN #QualityManagement #MedicalDevices #InternalAuditing #ISO13485 #Compliance #ImedConsultancy #Regulatoryconsultancy
IMed Consultancy Ltd
医疗设备制造业
Bloxham,England 2,948 位关注者
QA/RA Medical Device & IVD Consultancy UKRP - QMS - MDR - IVDR - ISO 13485 - CE Marking - Global Submissions - UKCA
关于我们
We are a medical device regulatory and quality consulting team working with people and their companies to navigate the minefield of todays global medical device regulations to ultimately achieve compliance and success. If you are a start-up company looking for some initial advice through to one of the big boys needing resource for a specific project or training for your team we can help. More importantly we want to help because we love what we do. Working with a team of industry experts as well as our core team we work hard with you to achieve your goals, transfer our knowledge and get you to where you need to be. Along with our flexible, friendly, no nonsense approach ensures we build long standing relationships with our clients based on trust and an in depth understanding of their business. We'd love to hear from you! Call us on +44 (0)1295 724286 or email [email protected]
- 网站
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https://www.imedconsultancy.com
IMed Consultancy Ltd的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 11-50 人
- 总部
- Bloxham,England
- 类型
- 私人持股
- 创立
- 2012
- 领域
- MDR、CE Marking、Medical Devices、In Vitro Diagnostics、Auditing、MDSAP、QMS、FDA、Global Registrations、Clinical Evaluations、Risk Management、Regulatory Affairs、Technical Files、IVDR、ISO 14971、21 CFR Part 820、ISO 13485、Health Canada、510k、TGA、IVD、UKCA和UK Responsible Person
地点
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主要
Barford Road
GB,England,Bloxham,OX15 4FF
IMed Consultancy Ltd员工
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Leeanne Baker
QA/RA Medical Device & IVD Consultant assisting with UKRP, UKCA, CE Marking, MDR, ISO 13485, FDA, QMS, Global Registrations & Audits
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Darren Clarke
Sales Coordinator at IMed Consultancy
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Matt Burton
Strategic Development Director, Principal Consultant, UKRP, EC REP, PRRC Services, Devices & Borderlines QARA at IMed Consultancy Ltd
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Jonathan Ripley MTOPRA
Managing Director at IMed Consultancy Ltd
动态
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We’re thrilled to share that IMed Consultancy Ltd is featured on Manufacturing Chemist, the go-to platform for all things pharma and life sciences. Check out our dedicated page to learn how we’re driving innovation in regulatory affairs, clinical development, and medical device consultancy: https://lnkd.in/dFg_jNqW At IMed, we’re passionate about partnering with life science organisations to navigate the complexities of compliance, accelerate time to market, and bring groundbreaking solutions to patients worldwide. Need support with regulatory matters? Contact us at [email protected] #IMedConsultancy #ManufacturingChemist #Innovation #RegulatoryAffairs #ClinicalDevelopment
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There’s a new Success Story on our website! Find out how IMed Consultancy supported HMNC Brain Health in getting their Cortibon programme’s clinical trial off the ground here: https://lnkd.in/dTZ8-sM5 #imedconsultancy #hmncbrainhealth #successstories #cortibon #clinicaltrial
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If you’ve missed out on any of our analysis and insights from October, check out our newsletter “Under IMed’s Lens” and subscribe to keep up with #regulatory and #compliance updates and other medical device or IVD news! #imedconsultancy #newsletter #monthlynewsletter #meddev #medicaldevice #ivdr #news #updates
Under IMed's Lens - October 2024
IMed Consultancy Ltd,发布于领英
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Check out Timothy Bubb’s latest article published in On Drug Delivery: Navigating the AI revolution in the Medical Devices sector: between innovation and regulation" In this piece, our Technical Director delves into how AI and machine learning are transforming the healthcare and drug delivery industries, with insights into the differing regulatory approaches taken by the EU, US FDA, and UK MHRA. As AI reshapes healthcare, understanding regulatory pathways is vital for ensuring these cutting-edge technologies reach patients safely and effectively. Read the full article here: https://lnkd.in/d6KaSQ6r #AIinHealthcare #MedicalDevices # #IMedConsultancy #Regulation #Innovation #DigitalHealth #OnDrugDelivery #HealthcareTransformation
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If there’s one thing we love at IMed is a #challenge! Find out how neither limited time nor a five-hours’ time difference stopped us when getting Toby Orthopaedics, Inc ready for an audit here: https://lnkd.in/deEm-TSy #imedconsultancy #imed #successstories #tobyorthopaedics #miami #clienttestimonials Gina De la Pava
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From diagnostic imaging and personalized medicine to wearable health devices and robotic surgery, AI/ML is revolutionizing how healthcare is delivered. But with innovation comes regulatory complexity. In our new blog we dive into the fast-evolving world of AI/ML-powered healthcare solutions. Explore how regulatory bodies are addressing the challenges of ensuring safety and efficacy for AI/ML in medical devices and how developers can navigate these evolving landscapes. Visit our website to read the full blog and make sure to follow us for more updates and upcoming blogs in this series! https://lnkd.in/d5hQG2mS #IMedConsultancy #DigitalDilemmas #AI #ML #DigitalHealth #MedicalDevices
Digital Dilemmas: an overview of AI and ML in medical devices and digital health products
IMed Consultancy Ltd,发布于领英
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#tbt September 12th, when?IMed Consultancy Ltd’s team got together for a day dedicated to reviewing our goals for the year ahead at Oxford Trust, a local hub supporting innovators in developing their technology and products. The team also attended a session in the STEM area run by Oxford Trust to view science in action and test our problem-solving skills on the exhibits. Its a fantastic resource that children, schools, families and adults use and a great way of reminding us of how science and technology can shape our world. We’re now ready to face all #2025 has in store for us, and we’re more committed than ever to supporting #innovative businesses and cutting-edge technology! Jonathan Ripley MTOPRA Leeanne Baker Al Mills Dipty Gadia Matt Burton Brian Aderson Caroline Timberlake Jacob Tyson Darren Clarke Jade Fraser #imedconsultancy #teamday #readyfor2025
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CPI have again announced a total fund of £4.2m, available to help small and medium sized enterprises (SME's) take on the Regulatory challenges involved getting their innovations to market. This programme is funded by the Office for Life Sciences through the Department of Sciences, Innovation and Technology and delivered by CPI. Applications for up to £30,000 can be submitted to receive regulatory support by qualifying companies developing and innovating products in the Medical Technology (MedTech, diagnostics, including IVDs, and software as a medical device (SaMD) space. The first 300 applications will go through a competitive scoring review and awards of funding will go to the highest scores until the total fund is fully allocated. Applications open on the 09 October 2024 and close midday on the 31st October 2024 and nominate a single regulatory provider. As an authorised regulatory services supplier of CPI, IMed Consultancy Ltd has a proven track record and partnered with many innovators and SMEs to assist in the development of their products and navigate regulatory hurdles. We are passionate about bringing MedTech solutions to market for the next generation of healthcare and more importantly to improve patient outcomes worldwide. If you have questions or would like support with your application, please get in touch and our team of experts will guide you through. https://lnkd.in/gdZaE6HZ
New £5m Accelerator Programme to Support UK MedTech Innovation | CPI
uk-cpi.com
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On Thursday October 10th IMed’s Strategic Development Director Matt Burton will address challenges and opportunities of bringing medical technology to the market at Day 2 of the UK MedTech to Market Programme. Below some pics from Day 1 of the programme, on October 1st. Read the full agenda and register here: https://lnkd.in/d6NHNjat ? #ImedConsultancy #MedTechtoMarketProgramme #speaker Newable Lynn Finch Health Tech Enterprise