ISO 13485 (Medical Devices) Consultancy

ISO 13485:2016 Consultancy

ISO 13485 Background

ISO 13485 specifies the requirements for a quality management system for medical devices. In the medical devices industry, organization have to comply with the customer requirement and most importantly, meeting the applicable regulatory requirements relevant to the specific medical devices. In some countries, manufacturer is compulsory to certify to ISO 13485 to demonstrate their ability to produce the products that meeting the requirements.

Organizations that involved in the medical devices manufacturing or provide the related services to the medical devices are eligible to certify to ISO 13485.

Organization have to determine their role in the ISO 13485 QMS such as manufacturer, authorized representative, importer or distributor etc., this is important as from the roles, we can defined which clause in ISO 13485 is applicable or not applicable to an organization.

Our consultants are from the medical devices industry (manufacturing related), and able to share with your organization on the best practices in this industry and support your organization to develop / enhance / maintain a good QMS. Contact us to discover the available package for the ISO 13485.