Posts

The Role of ISO 14971 in Global Medical Device Regulations

Image
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

Image
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...