Medical Device Risk Management Tools: Assessing Your Options
Medical device manufacturing is highly regulated, with a ceaseless requirement to minimize and mitigate risk in design, development, and manufacturing.
Software solutions can help to ensure consistency and objectivity in the creation, auditing, and monitoring of vital risk management processes.
But as a medical device manufacturer, how do you know if your risk management tools are fit for purpose?
Spreading Risk With Spreadsheets
Sometimes the most basic tools are the best ones for the job – if that job is relatively simple. We know that medical devices are highly complex, so using spreadsheets for designing, organizing, and analysing data can lead to errors which require extensive verification and could lead your business open to potential challenges from regulatory authorities. In turn, they can create delays to market, rejections, post market problems and complaints – even potential lawsuits.
Introducing multiple projects and variants, such as risk scoring, the potential for errors becomes exponential. This could delay commercialization or even create a flawed process or product with dangerous outcomes.
That’s why many medical device manufacturers are utilizing structured software solutions to substantially reduce the administrative burden and eliminate potential errors.
Regulatory Reliability In Risk Management
Medical device customers complete a comprehensive list of regulatory questions to improve their risk analysis and management, and meet rigorous regulatory requirements. Regulatory authorities focus on product safety from a 360 degree perspective, identifying the potential ways someone could be harmed from normal use or possible misuse of a device. Manufacturers also analyse hazardous situations, hazards, and harms including mitigation activities to create a device with acceptable risks.
In each country or region, these regulations differ. The EU Regulations for medical devices (MDR) changed the rules on how to submit information. In the US, FDA rule changes have also required overhaul of submissions. Additionally, there are a number of industry standards to factor in, such as ISO:14971, which covers risk management for medical devices. In addition to that, most organizations set their own processes and procedures, which have further layers of compliance and risk management.
All in all, medical device manufacturers need scalable compliance solutions that are fit for purpose, with risk tools that provide a comprehensive set of templates.
Turning To Trusted Solutions
When it comes to understanding the constantly evolving compliance implications of medical device manufacturing, you need solutions you can trust.
Although, risk management is not confined to the medical device and pharma industries, the terms “risk,” “harm,” and “hazard” have far-reaching consequences for patient outcomes. They demand a process which is internally checked, and provides a clear audit trail with parameters that can be verified by accessing an online library of all types of hazards, depending on the device application.
In order to grant approvals, regulators need to have the evidence that the structured data makes sense, and confirms the potential risk. Ensuring this not only increases credibility, but also demonstrates that a robust and thorough process is in place.
Spreadsheets have their place, but they should not be the default for the complex risk management and compliance of medical device companies that need to get products to market quickly and safely.
