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.
Austrian Pharma Services offers multiple decades of combined experience helping Pharmaceutical and Biotech companies improve their compliance through hands-on service, training and consulting.
Their main areas of expertise are Quality Management Systems (per ISO9001, ISO13485, GDP, GMP per Eurdralex and 21CFR) - end-to-end. Either you book them on a project basis or hire them as a Contract Quality Organization (Quality-as-a-Service).
Based in Switzerland, Avanti Europe is a specialist consultancy and expert knowledge provider for the life science industry including medical devices, in-vitro diagnostics, and combination products. Avanti offers an 1-stop-shop approach to flexible, tailor-made consulting and contracting resources and acts as Contract Consulting and Development Oganisation (CCDO). Avanti Europe further supports with QA/RA-services, such as CH/EC REP, PRRC, and digital (knowledge) products, such as rent-a-qms, automated compliance monitoring via https://prexevus.com/ or its magazine "across Europe”.
Benten Creative are a team of medical device professionals with over 70 years of combined experience. Our consulting practice has helped all types/sizes of companies effectively create, update, and audit Quality, Regulatory, Engineering, Clinical, and Training services. Our capable team, made up of former Notified Body professionals and industry experts, will join forces with you to create or enhance a quality system, formulate a regulatory strategy, or initiate a clinical trial, all tailored to meet your specific requirements.
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.
At Cannon Quality Group, we’re committed to improving quality in the MedTech world. We’re experts in Quality Management systems. We don’t just build them; we make sure they’re the right size for your needs. We don’t stop there. We also have a great team of experts who are handpicked to work seamlessly with your organization's unique needs.
Quality isn’t just about following rules; it’s what turns a functional product into a life changing one. We're here to make sure your product changes peoples’ lives --- we believe in the transformative power of quality. At Cannon Quality Group, we're not just about following rules; we're about shaping the exceptional.
Daedalus compliance path is a comprehensive ISO 13485 eQMS and compliance system designed to reduce development costs, speed time-to-market and manage risk. Our mission is to transform regulatory compliance from a roadblock hindering innovative medtech entrepreneurs into a gateway to global market access. We do this by providing a highly cost effective cloud hosted solution designed to guide early stage medtech businesses through the maze of regulation and international standards with clarity and efficiency.
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.
JReg Consultancy Ltd. is a team of experienced professionals offering a broad spectrum of regulatory, clinical and quality compliance services to assist both domestic and global companies in obtaining the necessary approvals and certifications to place and keep your medical device product on the market.
Rallis-Daw Consulting LLC is a woman owned business located in San Clemente, CA offering a wide array of services to the life sciences industry including but not limited to full quality management system implementation (QMS/eQMS), gap analyses and remediation, technical writing, regulatory submissions, program management, organizational training, mentoring and women empowerment initiatives.
Simbex is an experienced medical device and consumer health product design and development partner that excels in transforming your most complex ideas into game-changing commercial solutions. Their track record of success in the health industry along with their deep technical, analytical and commercialization know-how reduces development and implementation risk to deliver and launch innovative products.
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.