Certification Overview ISO 13485:2016 is a standard that defines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory requirements, an organisation does not need...
In some markets, such as the European Union and Japan, medical device manufacturers must obtain ISO 13485 certification. In the EU, the requirements of ISO 13485 have been harmonized with the essential requirements of the EU’s Medical Device Directive (93/42/EEC), the Directive for In Vitro ...
Who needs to gain ISO 13485 Certification? ISO 13485 is suitable for all the manufactures or suppliers referring medical equipment, components, contract service and medical equipment distributors. Our professionalism has brought thousands of worldwide organization confidence and guarantee. You can meet wit...
Passed FDA, CE, ISO, GMP, FSC and etc certification.Best service and nice quality with competitive price. Send your message to this supplier *From: *To: *Message: Enter between 20 to 4,000 characters. Send This is not what you are...
ISO 13485 certification establishes a company’s credibility and dedication to quality. Prospects recognize the value the certification and understand the investment in quality a company makes to earn it. Marketing and promotional benefits Companies deemed ISO 13485 compliant receive a certificate which ca...
ISO 13485 is intended for use by enterprises engaged in the development, manufacturing, distribution, and maintenance of medical devices and associated services. Organizations inside and outside the company, like certification agencies, could use it to help with auditing. ...
Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, contact our expert team who will guide you through the process. Email us atmedicaldevices@bsigroup.com Request a quote ...
Passed FDA, CE, ISO, GMP, FSC and etc certification. Best service and nice quality with competitive price. Send your message to this supplier *From: *To: *Message: Enter between 20 to 4,000 characters. This is not what you are looking fo...
Complete an initial certification in a phased approach ISO 13485 Compliance The International Standards Organization (ISO) creates documents that provide guidelines to ensure that products, processes or services are fit for their manufactured use. Standards ensure the quality we’ve come to expect in ...
Certification qualification display As a Chinese manufacturer of medical wires, cables and electronic products certified by ISO13485, Dongguan Goochain Technology Co., Ltd. always adheres to international quality standards and uses a rigorous quality management system to ensure the reliability and safety ...