Arazy Group Consultants Inc. noted that new amendments introduced greater flexibility for Class I device transitions, product modifications, and supporting documentation in South Korea.
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Three markets. Three regulatory shifts. One message for MedTech companies: regulatory expectations are changing fast. Here are three key developments from August that co…
Company
Arazy Group Consultants Inc.
Medtech Regulatory Affairs Technology explicitly designed for Regulatory Affairs Professionals like you!
- Industry
- Medical Equipment Manufacturing
- Location
- Vancouver, CA
- Company size
- 11–50 employees
About Arazy Group Consultants Inc.
Arazy Group Consultants Inc. is the inventor of global medtech registration technology providing services and products designed to streamline, simplify, and expedite international market access affairs for all types of medical and IVD devices. With the launch of LICENSALE® - Global Medtech Registration System in 2013, Arazy Group took the lead on the provision of advanced registration and license management technology solutions, designed specifically for the medical and IVD device industry. Staying true to its company mission to make the best medical devices and medical practice available to patient and physicians around the world, LICENSALE® delivered thousands of new products registrations, amendments, renewals, and transfers of licenses over the past seven years. Leveraging on their experience and the latest advancement in software, database management, machine learning and A.I., Arazy Group developed the next generation in MedTech registration and license management software- LICENSALE® 2.0, REGISLATE® and the EUDAMEDtech© system Advanced solutions rapidly adopted by the global medtech industry and becoming the gold standard of market access license management. Arazy Group is based in Vancouver, British Columbia, Canada. Arazy Group has additional offices in the US, Argentina, Israel, Turkey, Korea and throughout Europe and is operating globally in 140 countries. Please contact us for more information or visit our website: http://arazygroup.com.
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Latest activity from Arazy Group Consultants Inc.
9 signals
Research & Knowledge
Arazy Group Consultants Inc. notes that the Medical Device Authority (MDA) has published the first edition of MDA/GD/0072: Change Management for Registered Medical Devices introducing a risk-based framework for managing modifications to registered devices.
Legal & Regulatory
Arazy Group Consultants Inc. notes clarified pathways and simplified requirements for certain European-aligned devices in Egypt.
Legal & Regulatory
Arazy Group Consultants Inc. highlights higher expectations for clinical evidence, patient diversity, and RWD/RWE in Canada.
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