Bolstering Your Post-Market Efforts

Getting your combination product to market is just the beginning! EdgeOne Medical provides ongoing support through post-market surveillance, helping you maintain product safety and compliance while also expanding into new markets long after the initial market approval.

Responsibility Increases After Launch

Getting a combination product to market is challenging, but maintaining it there comes with even greater responsibility.

Ongoing post-market support is crucial to ensuring continued product safety and compliance, often while in parallel managing market expansion efforts.

Device Related Activities Continue

Having robust listening and feedback systems and processes in place to monitor product safety and effectiveness in the field is critical for both constituents of combination product: drug and device. It provides a real-world feedback loop that identifies new risks to consider or product refinements that are necessary. At EdgeOne Medical, we offer critical product sustaining services that support receiving and responding appropriately to real-world use.

Specialized Post-Market Support Services

Once your product is on the market, EdgeOne Medical services help investigate patient feedback, refine the device based on real-world data and expand into new markets. Below is a sampling of the most requested services we offer in support of your marketed products.

Release Testing

When your contract manufacturer can’t perform necessary device related release tests, our FDA and EMA registered labs handle the testing and issue Certificates of Analysis for final release decisions.

Complaint Investigations

We conduct thorough complaint investigations in our FDA and EMA-registered labs, working closely with your quality team to understand product issues observed in the field quickly and effectively.

Life Cycle Management Changes

Whether a device component needs updating due to a supplier change or as a result of customer complaints, we assess the impact of the change on your device documentation, create an implementation plan and execute against the plan efficiently and effectively.

Market Expansion Services

Expanding into new markets? We’ll help you compile necessary technical files and perform tests tailored to each region, leveraging existing data and documentation packages to streamline the process.

The EdgeOne Advantage

Bringing your combination product to market is a milestone, but the real challenge lies in maintaining its success over time.

The foundation of device expertise, services and unique infrastructure that EdgeOne Medical provides to emerging pharma clients throughout development is the same foundation that supports commercially marketed products.

Our expertise, infrastructure and device-focused post-market services offer emerging pharma companies’ peace of mind that the device constituent will remain complaint throughout its life cycle..

Your Post-Market Surveillance Questions, Answered

We know emerging pharma companies often have questions about the complexities of post-market surveillance. Here are some of the most common questions we receive and how we can help.

: In preparation for clinical or commercial use, appropriate listening and reporting systems should be in place within your QMS to support the complaint handling process. When complaints on the device occur, those specific devices will need to be returned and investigated in a lab to help support root cause analysis. EdgeOne Medical actively supports our clients with complaint investigations of their devices to quickly identify root cause. Reach out to learn more.
: Yes. In general, device development follows international standards such as ISO 13485, ISO 14971 and IEC 62366 so the information generated is expected to be aligned with expectations from other markets. Additionally, most countries are aligned with the fundamental approach towards combination product development where both constituents are expected to be developed according to the regulations that govern each constituent if they were stand-alone products. However, some markets may require unique documentation or data. It is important to perform a regulatory assessment of the requirements for each market to identify any additional device development activities.
: Yes, changes post-launch happen for a number of reasons. Prior to implementing a change, a documented change management process must assess the impact of the change on the design as well as production of the product. The impact assessment identifies activities that must be completed prior to implementation of the change. Some of these activities could include re-testing, updating risk documentation, and/or a new submission to a regulatory agency.

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