Regulatory consulting and quality management system implementation for medical device manufacturers. Supports EU-MDR 2017/745 compliance assessments, conformity documentation, and QMS establishment. Includes regulatory documentation, expert evaluations, and audit coordination to ensure product safet...
Manufactured by
BEO MedConsulting Berlin GmbH
Berlin, Germany
BEO BERLIN advises manufacturers on the testing and approval of medical devices and listing in the medical aids directory. As an interface to inspection bodies, authorities and associations of statutory health insurance physicians, BEO BERLIN supports companies in meeting the requirements placed on manufacturers themselves, their medical devices and their documentation. BEO BERLIN provides these services both nationally and internationally. The company is also a competent partner for the introduction of quality management systems. BEO BERLIN also offers seminars on medical device law. The consulting company thus positions itself as a comprehensive service provider in the healthcare market. BEO BERLIN advises manufacturers on the testing and approval of medical devices and their inclusion in the Medical Devices Register. As an interface to test centers, authorities and associations of statutory health insurance physicians, BEO BERLIN supports companies in meeting the requirements placed on the manufacturers themselves, their medical devices and their documentation. BEO BERLIN provides these services both nationally and internationally. The company is also a competent partner for the introduction of quality management systems. BEO BERLIN also offers seminars on medical device law. The consultancy thus positions itself as a comprehensive service provider in the healthcare market.
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BioTop Medical Dr. Teresa Lopes · Netherlands
Regulatory compliance and quality management consulting service for medical device manufacturers. Supports development of technical documentation, risk management files, and post-market surveillance plans required for European and North American market authorization. Provides hands-on management of regulatory affairs and quality assurance activities throughout device lifecycle.
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