Streamline Medical Device Postmarket Surveillance

In this blog, we recap a section our recent datasheet, “Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect” – Click HERE to read it in its entirety.

Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect

Postmarket surveillance (PMS) is an expected regulatory activity that plays a vital role in ensuring the safety and effectiveness of medical devices after they reach the market. The key to an effective PMS program is to ensure that the requirements and risks identified early in the development process are continually updated throughout the product’s lifecycle. Maintaining “living” design documentation allows companies to better identify, analyze, and respond to potential safety issues. As new information about the product comes from user feedback, clinical studies, or complaint reports, teams can review and update all product information in Jama Connect, allowing them to conduct better investigations and continually enhance the product as a benefit to patients.

Jama Connect for Medical Devices streamlines and simplifies the PMS process by providing a single source of truth for a product’s entire lifecycle. Whether it is managing requirements, performing risk analyses, or conducting effective change management, companies can meet all regulatory requirements and provide patients with safer and more effective devices.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

KEY BENEFITS:

Improve Postmarket Surveillance by Using the Same Platform During Development and Post Launch: Jama Connect is a full lifecycle platform that allows companies to manage requirements, testing, and risk analyses both during development and after launch, ensuring all PMS activities are managed efficiently and reliably.
Enhance Risk Management Through Structured Collaboration: Build or easily migrate risk management items into Jama Connect so that internal and field-based teams can work together to collect and analyze product safety information and implement better corrective and preventive actions faster.
Modernize Change Management by Maintaining a Living Design Documentation File: Create a real-time view of all product design and risk information in Jama Connect and utilize automated workflows to conduct change management activities.

Seamlessly Transition from Development to Surveillance

Jama Connect’s ability to create Live Traceability™ across your development tool chain ensures that every step, from ideation to postmarket adjustments, is documented and traceable.

Organizations that use Jama Connect for managing requirements, tests, and risk during development and postmarket surveillance can conduct investigations and implement product changes with greater speed and confidence to minimize the impact on patients and the company.

Finding success in Jama Connect is not just limited to those starting a new project from scratch. A company with many existing projects can transfer all requirements and risk information using migration solutions and services provided by Jama Software. This will create a strong foundation that helps the organization enhance postmarket surveillance activities and improve future development.

DOWNLOAD THE ENTIRE DATASHEET TO LEARN MORE:
Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect

Author
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Tom Rish

Senior Product Marketing Manager at Jama Software

Tom Rish is a biomedical engineer with over 15 years of experience developing medical devices. His work has spanned the entire MedTech product lifecycle, from initial concept through market launch. He is passionate about helping others navigate the complex journey of bringing a device to market so that patients around the world can benefit from life-changing technologies. Tom is currently a member of the Product Marketing team at Jama Software.

Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect®

Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect®