Quality

Medical Device Risk Management

Medical device manufacturing is trending toward Industry 4.0. Digitized quality risk management software gives you a more thorough and consistent approach to managing and resolving risks.

Medical device manufacturing is highly regulated. Compliance depends on proper risk management. Companies should deploy risk management software to unify all risk-related activities, enabling staff from multiple departments to collaborate in risk assessment and mitigation. Automatically track and trace risks. Effectively analyze trends to ensure you can correctly rank and resolve issues.

Free Resources

The Ultimate Guide to Medical Device Quality Management

Frequently Asked Questions (FAQ) About Medical Device Risk Management

How do you mitigate risk in medical devices?

MasterControl’s quality risk management software for the medical device industry.

Employ risk-based thinking. Set up a system for effectively aligning people, processes, and technology. Defects or discrepancies commonly go undiscovered until later in the production process or postmarket. Medical device risk management needs to start earlier and be performed in greater detail and at every stage of the product’s life cycle.

What is the difference between ISO 13485 and ISO 14971?

ISO 13485 focuses on integrating active risk management in quality processes. It includes documenting requirements and maintaining risk management records throughout the product’s life cycle. ISO 14971 applies to identifying and controlling risk with intended use, foreseeable misuse, and hazardous situations throughout the product’s life cycle.

What are the 7 principles of risk management?

Every organization differs on risk management. Still, most risk management strategies include these principles:

Identify risks early.

Include organizational goals and objectives.

Manage risk within context.

Involve stakeholders.

Clarify all roles and responsibilities.

Create a cycle of risk review.

Strive for continuous improvement.

Medical Device Risk Management Resources

Select the free resources you’re interested in downloading

White Paper: 6 Must-Haves for a Quality Management System (QMS)
Buyers Guide: QMS Buyer’s Guide: Finding the Right Fit for the Future
Ultimate Guide: The Ultimate Guide to Medical Device Quality Management
Industry Brief: Simplify CAPA in 7 Steps
FAQ: 21 CFR Part 820 – ISO 13485 Harmonization

Identify and Resolve All Risks

Medical device risk management is challenging and complex. It’s more than just checking boxes for compliance. It requires efficiency methods for ongoing tracking, controlling, reviewing, and communicating risks to ensure product quality and safety.

Often risk management is viewed as a requirement only to meet compliance.

MasterControl’s nonconformance management software - Automates the processes involved in managing nonconformances.
Delaying risk management processes results in add-on costs and delays.

MasterControl Quality Excellence - Digitized solution ensures quality across the product’s life cycle.
Complex and undocumented quality risk management leads to undetected risks.

MasterControl Risk - Gives you a complete view of your enterprise risk landscape.
Lack of integrated quality risk management creates gaps and noncompliance.

MasterControl's QMS - integrates with all other quality processes for a holistic approach to quality.
Lack of training leads to quality issues slipping through the cracks.

MasterControl Training - Streamlines training tasks, including routing, tracking, and follow-up.