A Quality Management System right-sized to your needs
Digitise your document control
Phase gate and document your entire design process
Fast and secure information management
Ensure oversight and control with graphical business management
Detect, correct and prevent quality failures
Integrate FDA and ISO 13485 compliant e-signatures into your eQMS
Monitor and manage supply chain quality
Tracking and self-attestation made simple
Change control when it matters most
No obligation live
60-minute demo
Acclaim Biomedical Consulting (ABC) enables clients to manage their business successfully through a pragmatic and independent approach to regulation. Specialising in the Healthcare and Biomedical sectors, they deliver their services worldwide.
Based in Switzerland, Avanti Europe is a specialist consultancy and expert knowledge provider for the life science industry including medical devices, in-vitro diagnostics, combination products, pharmaceuticals, cosmetics and food industries. With flexible, tailor-made solutions and resources, Avanti Europe supports your projects, products and processes as ad-interim managers, consultants and experts in the environment of: Medical Devices, in-Vitro diagnostics, phytopharmaceuticals, homoeopathy, supplements, combination products, pharmaceuticals, generics/biosimilars, cosmetics and novel food.
CADARN-QR takes its name from a Welsh word meaning 'solid' or 'robust'. They are focused on helping clients achieve excellence in; QMS. internal & external auditing, product reliability & qualification strategies, lifetime predictions and failure analysis advice across a range of industry sectors.
Fast-Track QMS Consultants help medical device companies efficiently implement a robust and compliant quality management system and achieve certification. Their experienced QMS experts work closely with clients to provide consultancy services and document templates tailored to meet their needs. They can help with all stages of implementation, from gap analysis and planning, documentation, training, audits and certification guidance.
Ingenious Quality Limited - with over 30 years of experience in the Semiconductor and Electronics industries IQ help manufacturing organisations improve their management systems and product quality.
Based at Chatham Historic Dockyard in Kent, IVDeology works with businesses all around the world. They are a growing business of like-minded, friendly professionals who are passionate about Regulatory affairs specifically within the in vitro diagnostic medical device industry.
Mantra Systems provide expert regulatory affairs & EU MDR consulting services to medical device manufacturers based in the UK, Europe, the US and Asia. Their unique medical device regulatory consulting services combine industry expertise with the key skills of clinically-active medical professionals.
Primilis is a highly experienced quality, business and manufacturing consultancy that takes a pragmatic and effective approach to helping technology-based companies in the UK and around the world become more successful. They have worked with Cognidox since 2009 and were the original creators of what is now the Cognidox gBMS platform; no-one has more experience of using the gBMS to successfully develop and deploy quality and business management systems.
Psephos is a medical device regulatory, clinical and quality consultancy. They are a highly focused, experienced team that provide regulatory, clinical and quality services to manufacturers and producers of Class I medical devices through to high risk Class III medical devices, covering areas such as Digital Health and AI, Cardiovascular, Neurovascular, Surgical Diagnostic and Invitro Diagnostic Devices (IVDs).
Shelley Quality Management Services LTD was founded by Samantha Shelley, who boasts over 25 years of experience in the medical device quality management and regulatory compliance industry. Their mission is to provide medical device start-ups with a flexible and cost-effective quality and regulatory resource.
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