How Medical Manufacturers Can Build an Effective ERM Program

In an increasingly globalized world, it’s becoming more difficult for heavily-regulated industries such as oil and gas, airlines, pharmaceuticals and medical devices to maintain compliance and manage risk. But while most industries develop and implement risk strategies to mitigate financial losses, medical manufacturers must prioritize patient safety over financial safety. If a safety-critical component fails, it’s a person’s life that is at stake.

For this reason, it’s important that you have integrated, scalable processes for managing risk, compliance and data governance with enterprise risk management (ERM). ERM manages risk and uncertainty by evaluating operational, financial and strategic risks. But can the holistic approach of ERM provide benefits across a medical manufacturer?

Integrating Risk, Governance Processes and Compliance

Medical parts manufacturers and pharmaceutical companies face many operational challenges as well as scrutiny from regulatory bodies. These dynamic and complex external factors include:

• Operating in multiple countries
• Legacy systems and procedures
• Fluctuating exchange rates
• Increases in prices for raw materials
• Transportation and logistics
• Scarce resources
• Changing global regulations

Meeting regulatory standards is, of course, one of the highest priorities and that means making sure your risk management process aligns with international standards, including ISO 14971.

ISO 14971 defines the international requirements of risk management systems for medical products. The first major phase in this process is risk analysis.

To ensure your company gets a product to market on time, within budget and without any defects, there must be successful implementation of a risk management system. No software can match Procipient® when it comes to supporting a single, scalable process for effective global decision-making.

Procipient® – The Sophisticated and Agile ERM Solution

Procipient®’s system-wide, integrated ERM-GRC approach can help medical manufacturers define the entire life cycle of their products. This advanced SaaS software offers a powerful solution for medical manufacturers and pharmaceutical companies that can help in:

• Implementing best practices that reduce risk for stakeholders
• Producing efficacious devices and therapies
• Managing quality, cost and speed to market
• Innovating quickly and optimizing speed of iteration

By employing Procipient®’s approach to organization-wide risk, medical manufacturers can safeguard assets, market share, certification, reimbursement levels and brand value. Most importantly, in an unpredictable and ever-changing world, Procipient® helps you improve patient safety.

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