Third-party assessment, inspection and audit services for medical device manufacturers and healthcare supply chains. Covers regulatory compliance monitoring, process validation, supply chain qualification, and ESG performance evaluation to support product safety and operational integrity.
Manufactured by
Certiquality srl
Milano, Italy
We provide specialised certification, auditing and professional training services. Certiquality, acting as Notified Body (no. 0546) for Regulation (Eu) 2017/745, performs all evaluations required to issue CE Marking certifications for Medical Devices . Our Mission is to facilitate profit and non-profit organizations as well as public administrations in the assessment and management of complexity. We provide training and assessment services on compliance and governance standards globally, aimed to optimize their skills for long-term sustainability and competitiveness.
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SigmaTech Nordic
Denmark · 1 relevant product
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3 of 113 closest product alternatives
SigmaTech Nordic · Denmark
Internal audit service for medical device manufacturers to assess compliance with ISO 13485 and regulatory requirements. Identifies gaps in quality management systems and documentation before formal certification audits. Supports CE marking preparation and ongoing regulatory adherence across European markets.
Precise testing & Certification(Guangdong)Co., Ltd. · China
Factory audit services for medical device manufacturers, providing compliance verification, quality system assessment, and regulatory documentation review. Supports manufacturers in meeting international standards and certification requirements for medical device production facilities.
UL Solutions s.r.l. · Italy
Quality Management System audit service for medical device manufacturers ensuring regulatory compliance and operational excellence. Provides independent assessment of QMS processes, documentation, and controls to strengthen compliance frameworks and support product safety standards.
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