- Overview
- Capabilities
- Managing Product Lifecycle
- Clinical/Initial Build
- Product Experience
- Managing Conformity Assessment
Managing Conformity Assessment
At CES MD we are well versed in navigating the maze of medical product conformity assessment.
The process begins by determining the Device Class and the appropriate Essential Requirements that are associated with the intended use of the device. This forms the criteria that a medical device must fulfill with focus and consideration on the safety, technical performance and clinical performance of the device.
Inherent in the essential performance requirements is a complete risk assessment with effective implementation of risk mitigation, reliability requirements, and testing based on the intended use of the device. Reliability tests are designed and performed according to product specifications to meet the Essential Requirements of the applicable Medical Device Directive.
To achieve conformity assessment, the manufacturer must show that the essential requirements are fulfilled. Key to this process is a solid plan which defines the sequences of developing verification and validation protocols, procedures, and reports in order to avoid bottlenecks which can occur during creation and the progressive submission of the technical file.
CES MD's experience and knowledge of the agency submission processes gives us the ability to help our customers get medical devices registered for market in an efficient and timely manner. Our ongoing working relationship with safety agencies facilitates quick feedback in order to keep a submission on schedule.
Areas of Expertise
- Risk Management Planning, Assessment and Mitigation
- Reliability testing
- Engineering Verifications
- Technical File Preparation and Construction
- Planning the process map of Reviews and Approvals
- Sequencing, Completeness & Content Review of Technical File