Documents
Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.
For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical...
read moreMedical Device Risk Management: An ISO14971 Update
In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental...
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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...
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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...
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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...
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Mobile Medical Apps
In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs)...
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Digital Health Innovation and Regulatory Compliance
Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based...
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Two Premier Medical Device Firms Merge to Provide More Comprehensive Services
Ashland, MA: MEDIcept Inc, a leading international quality and regulatory consulting firm focused on medical device and in-vitro diagnostics (IVD), and Reilly & Associates, a US-based privately held consulting firm specializing in medical...
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How Can You Outsource Quality Assurance?
If you’re a medical device manufacturer – and especially a smaller one, such as a recent start-up – the real question might be “How can you NOT outsource quality assurance?” Smaller firms such as start-ups are especially vulnerable to issues surrounding quality...
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What You Need to Know About GDPR
If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data...
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