Compass for medical device development
Compass is the only solution that truly integrates risk, requirement, and test management for a fully automated design control process. It includes built-in, enforced processes for quality management and adaptable document management functionality to meet all of your reporting and regulatory submission needs
In today’s changing regulatory environment, rapid compliance is more important than ever. Efficiently demonstrating system safety and efficacy is a top challenge facing medical product development teams.
Compass automates the development process.
Compass is key to your Quality Management System strategy
Efficiently demonstrating system safety and efficacy is a top challenge facing medical product development teams in today’s changing regulatory environment. It is key to market your technologies faster and set yourself apart from your competitors.
Overall regulation
“Manufacturers shall have systems for risk management (paragraph 2) and quality management (paragraph 9); compile technical documentation (paragraph 4); and apply a conformity assessment procedure (paragraph 6). ” – EU 2017/745
Risk Management
“The manufacturer shall establish, document, and maintain throughout the life-cycle an ongoing process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls.” – ISO 14971
Design Control
“Each manufacturer of any class III or class II device, and [some] class I devices … shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.” – 21 CFR 820.30
Document Control
“Each manufacturer shall establish and maintain procedures to control all required documents… The procedures shall provide for the following: (a) Document approval and distribution… [and] (b) Document changes.” – 21 CFR 820.40
Introducing Compass as a medical device development and compliance platform
Compass provides an adaptable set of templates for the entire product design control process: risk, requirement, and test management, from user needs to validation. Saving time and resources, it maintains documentation and supports submissions as well as providing automatic generation of the master trace matrices for the Design History File (DHF).
COMPLIANCE IS NOT OPTIONAL
Compass supports compliance with major industriy standards and regulations, including: IEC 60812, 21 CFR part 11, EU 2017/745, ISO13485, 21 CFR 820.30, ISO 14971, IEC 62366
SOFTWARE-AS-A-SERVICE (SAAS)
Compass can be hosted on-premise or on a secure EU-based SaaS environment provided by Synergio. Synergio’s SaaS offerings are compliant with ISO 27001 and 21 CFR Part 11. Access your project from a secure, shared environment made for collaboration.
TOTAL TRACEABILITY
Compass includes built-in mechanisms for allocating, linking, and tracing requirements, risks, and tests to help teams see the numerous connections from User Needs and Validation through to Design Outputs, Risk, and Verification. It automatically pulls in the data to generate complex master trace matrices, that can be exported and submitted as part of the Design History File (DHF).
RISK MANAGEMENT
Compass provides out-of-the-box templates for PHA, FMEA, FTA, and more. Scoring and color matrix options allow you to tailor the Compass experience. Risk calculations are done within the platform, reducing the room for error. The built-in risk functions can be configured to suit medical device or pharmaceutical products.
Why do leading medical device companies choose Compass?
- Compass supports efficient, evidence-based product development
- Complete traceability across all functional areas provides a single point of truth so that every action is accounted for and easily traced/auditable
- Out-of-the-box template functionality with the ability to adapt to your processes
- Automated enforcement of processes allows for alignment with quality management systems
- A single solution to author, approve, and archive Design History File (DHF) content
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See How Compass Can Help You Get to Market Faster, With Complete Traceability.
