MDSAP Audit The Medical Device Single Audit Program (MDSAP) was formed by the International Medical Device Regulatory Forum (IMDRF) to adopt a global regulatory approach and promote consistency and transparency by harmonizing the program. It consists of ISO 13485:2016 and regulations and standards of 5 participating countries. You can check out our page on MDSAP […]
What Are Some Common Non-conformities to MDSAP Audit? Read More »
Introduction to MD 15 License: License to Import Medical Devices in India India has emerged as a leading manufacturer of medical devices in the past decade. The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory body that controls the manufacture, distribution and sale of medical devices in India. It is also responsible for
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Operon strategist is thrilled to share exciting news for MedTech companies in the US. Medical device manufacturers can seek funding of up to $300,000 through the Advanced Manufacturing Clearing House program (AMCH). The Medical Device Innovation Consortium (MDIC) in partnership with the FDA has come up with a program – AMCH to expedite the adoption
FDA to Fund Medtech for Adopting Advanced Manufacturing Technology Read More »
SFDA Issues Guidance Document on MDMA The Saudi Food and Drug Authority (SFDA) recently released a guidance document to clarify between significant and non-significant changes related to registered medical devices. SFDA is a regulatory body regulating medical devices including IVD’s sold and distributed in Saudi. As per the document, any changes made to the registered
SFDA Regulations on MDMA: Significant and Non-significant Changes Explained Read More »
Operon Strategist stays on top of the latest developments in medical devices. Sharing another important and recent update: The Department of Consumer Affairs has sent a letter to the Department of Pharmaceuticals (DOP) requesting that medical devices must include key details on the package. “All medical devices will have to bear details like retail price,
Department of Consumer Affairs: All Medical Device Packages Must Display Key Information Read More »
Getting an FDA approval for your medical device can be a stressful task especially if you are new to the medical device industry. There are several processes and submissions before you send the final application for FDA approval. It is not a straightforward process and may require guidance from technical experts and consultants if it is your first time.
FDA Pre Submission: All You Need to Know Read More »
As a medical device consultancy, we are pleased to share a significant announcement made by the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Govt. Of India. The DoP recently announced the scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)”. Niti Aayog and the DoP had identified a few factors that
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Overview of ISO 13485 Internal Audit ISO 13485 internal audit is a critical component of a Quality Management System (QMS). It effectively identifies and addresses any potential risks or non-conformities. The internal audit checklist will help the organization ensure that its processes and procedures comply with the requirements of ISO 13485. If you are new
Ultimate Guide to Conduct an ISO 13485 Internal Audit Read More »
