Getting ISO 13485 Certified in San Jose, California (CA)
Quality control systems can not be compromised in the medical devices sector, which is why the legal standards are so stringent, and why certification is important. At ISO Pros in San Jose, California (CA), we recognize the value of preserving public safety, which is why we have helped you become certified with ISO 13485:2016.
ISO 13485:2016 is primarily intended for suppliers of medical equipment to ensure their quality control program ensures and maintains the consistency and safety of finished goods. Many organizations, such as medical equipment manufacturers, producers, importers, retailers, and installers may also gain from this certification. Although ISO 13485 is focused on ISO 9001, adding much of the same criteria, it includes additional controls that include:
- Additional data, authentication, evaluation and recognition criteria for regulations
- Focussing mainly on the management of risk
- Adaptation of global regulatory standards
When it comes to faulty products, there is no choice, which is why you can trust us at ISO Pros in San Jose, California (CA), offering several years of efficient and creative healthcare certifications.
Why you need to get certified
Companies with an ISO 13485 certification demonstrate a dedication to quality to all customers and regulators in today’s dynamic market place whether working globally or developing locally. It gives better exposure to more customers across the globe. Provides a framework for quality development of how to evaluate activities throughout the enterprise. And will enhance productivity, lower costs, and increase consistency in the supply chain.