EU MDR Gap Analysis

EU MDR Medical Devices - Regulatory Compliance - Celegence

An EU MDR Gap Analysis is your organization’s first step towards achieving maximum compliance with the EU MDR

An MDR Gap Analysis is your organization’s first step towards achieving maximum compliance with the EU MDR. At Celegence, we understand your current regulatory resources might be exhausted with the European Commissions’ new guidelines that aim to improve fair market access, as well as to optimize clinical safety. The companies who are not able to fully implement these changes will be severely disadvantaged in the highly competitive and innovative Medical Device industry once the MDR takes effect in 2021.

EU MDR Gap Analysis: Procedures, Processes & CE Technical Documentation

Celegence Gap Analyses are conducted by our team of regulatory specialists to facilitate a smooth transition for your organization. With our guidance, your team will know precisely which areas your organization needs to revise in accordance with the new MDR. Our Gap Analysis will examine the current status of your company’s regulatory affairs, with a focus on your procedures, processes, and CE technical documentation. A thorough gap analysis is paramount, and it will offer strategic dividends in the future with your upcoming clinical activities.

Our involvement after we complete your gap analysis is designed to help best fit your particular needs. With our customizable consultative services, we can put together a plan that will mitigate all of the regulatory gaps found in our analysis. After reviewing the findings with your team, your leadership will be able to aptly assess which aspects of the MDR transition can be handled internally, and which elements require outsourcing. We often see our clients struggle to adjust to the expanded requirements without increasing their own resources, thus, possibly leading to regulatory deficiencies due to budget constraints. That is why it is vitally important that your Regulatory Team is proactive in mapping out how you will address the changes within the MDR, and a Celegence Gap Analysis is the logical first step.

Medical Devices EU MDR Regulation - Celegence

Essential Components of the EU MDR:

  • EUDAMED

  • Post-Market Surveillance

  • Clinical Evaluation Plans and Reports

  • UDI

  • Notified Body Interactions

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Our medical device expertise also includes region specific support for submissions, and global regulatory consulting and intelligence.

If your team has not begun addressing any of these areas above, reach out today for a Celegence MDR Gap Analysis that will comprehensively examine all relevant aspects of your regulatory process.

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