-
BijinV replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
The companies that I have worked for that operate under any sort of regulation either purchase the standards or opt to use a subscription service. There are many regulations, and as has been mentioned, they are very expensive to purchase. However, these regulations are a necessary part of the cost of business as they provide guidance for the regulatory and quality measures a company needs. It should also be noted that standards also exit for other markets (europe, asia). The availability of international standards, in my experience, is significantly less expensive than many of the standards provided by the FDA and other NGO’s.