Expert Quality and Regulatory Consulting for European Medical Device Compliance
Successfully navigating the complexities of medical device regulations in Europe requires expertise and a strategic approach.
At Keane MedTech, we specialize in providing end-to-end quality and regulatory support for medical devices of all classes. With over 20 years experience in the medical devices industry, our goal is to help you achieve and maintain compliance across the European market, from regulatory strategy development to comprehensive post-market surveillance. Our support can be tailored to meet the varied needs of companies whether start-ups or established SMEs or multinationals.
Led by Principal Consultant and Director Orla Keane, we are here to help you succeed—whether you need guidance on a single project or longer term compliance support.
Contact Us
hello@keanemedtech.com
Services
Audit Support and CAPA
Full audit support including internal audit programme, mock audits and remediation support following findings from external audits by Notified Bodies and regulatory authorities.
Support to streamline and strengthen your Corrective and Preventive Action (CAPA) processes to enhance compliance and promote continuous improvement.
Regulatory Strategy & Authority engagement
Develop a clear, customised regulatory pathway for the European market, appropriate to the classification of your device, including engagement with relevant reguatory authorities to support approval processes.
Post-Market Surveillance and Vigilance Support
Support proactive management of post-market obligations including incident investigation and reporting and effective execution of field safety corrective actions.
MDR Economic Operator Compliance and QMS development
Expert guidance on fulfilling the regulatory responsibilities of manufacturers, distributors, importers and authorized representatives under the EU MDR, including development and maintenance of Quality Management System (QMS).