The company's core activity is advising and supporting companies in the medical technology industry in implementing and optimizing quality management systems, conducting audits, and complying with regulatory requirements, particularly in the areas of FDA and ISO standards. The company also provides training, coaching, and consulting services in the areas of medical devices, plastics technology, metal industry, and cleaning technology.
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Products & services
Industry:Medical Technology Industry
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Leadhub delivers verified contact details and decision-makers from over 750,000 Swiss companies — management, procurement, marketing, HR.
Regulatory consulting for medical devices, development process and V&V, risk management, MDR technical documentation, clinical evaluation, as well as approval strategies and submission files.
Quality Management Services
Support for quality management systems, computer system validation, qualification and validation, QMS for testing and calibration laboratories, and support for healthcare institutions.
EU MDR / CH MepV
Support for manufacturers, suppliers, importers and distributors regarding EU MDR and CH MepV, incl. EU/CH-REP, technical documentation, clinical evaluation and market surveillance.
FDA Services
Support for FDA readiness and inspections, FDA registration and US agent, as well as FDA submissions for manufacturers and suppliers.
Training and Courses
Training on medical technology topics with practical focus, pre- and post-work, workshops, and EDUQUA-certified instruction.
Knowledge
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