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FSMA Preventive Controls: What Indian Food Companies Must Know for 2025

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As 2025 approaches, Indian food companies find themselves at a make-or-break moment where following food regulations also opens new doors. The Food Safety Modernization Act, or FSMA, has turned the worldwide food safety game upside down by moving us from patching things up to stopping problems before they start. If you plan to export food to the U.S., FSMA has become the must-have pass for the global market, not a nice-to-have sticker. This change is not just about checking boxes; it's an invitation to become a market leader. By adopting preventive steps and up-to-date safety practices, Indian producers can boost their reputation, keep customers safe, and earn the trust they need to succeed worldwide. Getting FSMA right today is the best way to build a safer, stronger, and bigger bottom line for tomorrow. Getting the FSMA Rewrite Head Start FSMA is the most significant rewrite of U.S. food safety rules in over 70 years. The new law instructs us to stop waiting for problems to explo...

What is IVDR Certification and Why is it Important for IVD Manufacturers

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  It's striking, yet true, that the global market size for in vitro diagnostics is projected to show a compound annual growth rate of 5.34% until 2030. Now, this massive growth comes with new rules. Medical device companies in Europe are now required to adhere to more stringent regulations. Among those changes is obtaining IVDR certification for their products. IVD remains the largest market in the global medical devices market, representing 13% of the total devices market as of 2024. But with growth comes responsibility. Companies must demonstrate that their products are safe and effective. This is where IVDR certification is critical. What Is IVDR Certification? IVDR is the short form of In Vitro Diagnostic Regulation. This rulebook from the European Union comprises rules for medical tests that doctors administer to determine if you have any illnesses. Consider blood tests, pregnancy tests, COVID-19 tests, or those genetic-testing kits. All of these require IVDR certification ...

The Role of ISO 14971 in Global Medical Device Regulations

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Imagine introducing a life-saving medical equipment to the market, only to have it rejected by authorities around the world because it lacked the necessary risk management documentation. In the medical device business, this unfavourable situation occurs more often than you might think. With the global medical devices market worth $542.21 billion in 2024 and expected to grow to $886.68 billion by 2032, the stakes are never higher for producers to get their risk management approach right from the start. Enter ISO 14971—the global standard that has established itself as the pillar of medical device risk management worldwide. This is not just another tick-box compliance exercise; it's your guide to safer devices, more efficient regulatory clearance, and better patient outcomes in the end.  Understanding ISO 14971 - The Foundation of Medical Device Safety ISO 14971 provides a structured approach to identifying, analyzing, evaluating, and controlling risks associated with medical device...

10 Reasons Every SME Should Consider for Acquiring ISO 14001 Certification

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Are you a small or medium-sized business owner, and assuming environmental management is beyond your budget for big companies only? You're not alone—it's high time you need realization. Increasingly, small firms find that going green isn't just good for the environment—it's profitable for their business. But how can ISO 14001 certification benefit your bottom line? Let's drill down.   ISO 14001 - A Brief Understanding To put it simply, it is an international standard for environmental performance. It lays down constraints on a firm's exploitation of natural resources, waste, and emissions control. This global 14001 ISO standard seeks to ensure that a business remains profitable. At the same time, it must show complete care for the environment. With such an ISO certification in India, a business enhances its brand image and proves it is taking a crucial responsibility for environmental impacts. At this juncture, SGS makes things smoother for those SMEs and othe...