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“MEDIcept has been easy for all to work with, they know a lot about out company and everyone actually enjoyed working with them. Their consultant, Fides Maldonado conducts herself as a professional, she added value to many projects and communicates with all the team members. She has been a big assistance to me and my team and I look forward to getting this project completed and then looking ahead to the next.”

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Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes

For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made the text of the Medical Devices Directives seem obsolete much earlier than anticipated. As a result, the European Commission authorized the development of a new set of industry requirements known as the Medical Devices Regulation...

MEDIcept Now Offers CRO Services

November 14, 2019, Ashland, MA – MEDIcept Inc., a leading international Quality and Regulatory consulting firm focused on medical device and invitro diagnostics, and ACMP Consulting, Acton, MA have entered into an agreement to provide Clinical Research Organization (CRO) services for early phase, pre-, and post-market studies to the healthcare industry. The MEDIcept/ACMP agreement will offer medical device companies full clinical operations support, including: protocol development, site...

Artificial Intelligence: What you need to know about next-gen smart medical device compliance

Recent strides in artificial intelligence (AI) and machine learning technology is opening the door to the development of increasingly smart medical devices capable of turning big data and digital information into actionable insights for healthcare professionals. AI is having a significant impact on the evolution of smart devices and how healthcare will be delivered in the future. AI, coupled with machine learning, is calling into question what it means to approve a medical device capable of...