Medical Device 13485 Step by Step Process

Collaborate and execute regulatory strategies for global registrations

- Assist in preparation and review of regulatory submissions to the regulatory authorities

- Support government interactions pertaining to medical device registrations and licensing

- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes

- Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle

- Support distributors with product registrations and renewals

- Provide regulatory assessment for manufacturing and design changes

- Support product regulatory intelligence and risk assessments

- Assist in maintaining compliance with product post-market requirements

- Support post-market regulatory actions taken for the products

- Assist in the review of advertising and promotional materials

- Support internal and external audits

- Ensure compliance with internal procedures and external regulations and standards

- Maintain and update quality system procedures

- Maintain quality records and other controlled documents