The global demand for medical devices has been steady in traditional markets despite the economic downturn and even increasing in some emerging markets. For medical device manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who want to compete effectively should also have in place a properly implemented and maintained quality management system.
Many manufacturers are discovering the benefits of working with a registrar because their experience and know-how provides a single source for certification to international standards and conformity assessments to medical device directives.
For example, your management system’s conformity with ISO 13485—“Medical devices—Quality management systems—Requirements for regulatory purposes,” from the International Organization for Standardization (ISO) can help you open the door to untapped domestic and international business opportunities, and reap the benefits of:
Expanded market access. National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
Reduced cost of sales. Your certification establishes your company’s credibility and commitment to quality. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence.
Improved performance. Based on a uniform and widely accepted system of process control, your certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.
While the process of breaking into a new market may seem confusing and at times a bit overwhelming, it can actually be broken down into five steps:
1. Determine if your product meets the definition of a medical device.
2. Classify your device.
3. Prepare technical documentation, and develop and implement your quality management system.
4. Fulfill premarket requirements and apply for assessment by a regulatory authority/conformity assessment body.
5. Maintain your quality management system and perform post-market surveillance activities.
The easy-to-use quick guide below summarizes the device classification, technical documentation, and quality systems requirements for medical device manufacturers in four of the world’s largest markets: the United States, the European Union, Japan, and Canada.