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sector

Medical Devices

Reduce time to market while improving compliance, safety, and data management: Quality System, Risk Analysis, Supplier Management…

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Increasingly demanding certification processes

Regulatory compliance is essential in the field of medical devices to ensure the safety of patients as well as the effectiveness and quality of products. Manufacturers are responsible for demonstrating the compliance of their devices, a process that can be lengthy and demanding. Furthermore, the regulations governing the medical device sector (MDR) constantly evolve: regulation 2017/745, ISO 14971, IEC 62304, FDA QMR, 21 CRF part 11, CE marking, clinical evaluation…

GxpManager application solutions help you demonstrate and ensure compliance throughout the product lifecycle, from design to manufacturing and beyond, with post-market surveillance.

Our solutions are designed to meet the needs of medical device manufacturers:

  • Applications that are natively compliant and pre-qualified to meet the requirements of highly regulated sectors: Infrastructure qualification, IQ and OQ platform qualification (drastically reduces the cost of validating applications generated with GxpManager)
  • Agile solutions capable of adapting to constant regulatory changes
Digitalizes risk analysis with GxpManger Applications Builder

Digitalized Risk Analysis

Risk management for medical devices is governed by ISO 14971, specifically for medical device manufacturers. Spreadsheet formats, often used to formalize risk analyses, are not compliant with regulations due to security, integrity, and data traceability.

With GxpManager applications, digitize and manage your risk analyses. Optimize the entire risk management process and ensure compliance with regulatory standards..

  • Manage the entire risk analysis process.
  • Compliance: all our applications are based on compliance-oriented features.
  • Real-time reporting: KPI tracking dashboards with GxpAnalytics.
  • Automatic publication of risk management reports: save valuable time by automating their publication.

Bouton “ Discover our risk analysis application” → lien vers application personnalisable / analyse de risques

eQMS: Choose a high-performing and auditable Quality Management System

Manufacturers of Medical Devices need high-performing, compliant, and easily auditable quality management systems to reduce non-conformities and have actionable and shared corrective plans.

With GxpManager, centralize your quality processes on a single platform:

Traceability (audit trail): track all changes to confirm the integrity and consistency of data submitted to regulations.

  • Simplify internal and external audits.
  • Management of quality documentation.
  • Management of quality actions related to non-conformities, complaints, and changes.
  • Training tracking

Benefits:

  • Significant time savings in managing your quality actions.
  • Better overview of compliance and operational quality management throughout the product lifecycle.
  • Real-time tracking of actions and tasks to be performed.
  • Overall quality system improvement compared to a system involving manual procedures (Spreadsheet, paper…).
  • Compliance quality system that can be audited
images of cubes with "certification ISO 9001" written on them
image illustrating the importance of risk analysis for medical devices

Data security

Regulatory authorities have noted that too many critical data are still recorded, stored, and approved in paper documents or Excel spreadsheets. This does not guarantee data integrity in terms of uniqueness, timestamping, signature, storage, and traceability of changes.

Data security is a priority for medical device manufacturers. They need solutions that ensure data integrity, availability, confidentiality, and auditability.

GxpManager ensures the integrity of your data by hosting your critical data in highly secure data centers located in France.

  • Access control to applications and data center security.
  • Data stored encrypted through cold encryption.
  • Updates and maintenance provided by GxpManager.
  • Business continuity plan (BCP) and continuity plan in place

 

GxpManager Platform:
The Power of No Code Low Code

Healthcare leaders have trusted GxpManager for over 20 years!

As a software editor since 2003, GxpManager has built on its business applications for the healthcare sector. This results in a thorough understanding of our clients’ regulatory and business challenges. We offer application templates that can be quickly adapted to your needs and custom solutions.

GxpManager is a No Code Low Code application platform on an annual subscription basis. Le LCAP allows you to create applications without programming, reducing the validation burden for generated applications.

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Traceability

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Compliance

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Security

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Agility

A specific need? We have the application…

we support you in building your application with our No Code / Low Code configurator

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