PDSVISION enables E2E unification of technical, quality and regulatory requirements

Keep up with the constant change of the regulatory compliance

The life sciences industry faces unique challenges and trends in the current climate. With a changing regulatory compliance environment, companies are looking for technology to help them stay competitive and maintain business continuity. To keep pace with these trends, it is essential for medical device companies to undergo a digital transformation. This transformation requires traceability and auditability of product data from product design to delivery of the product to the customer.

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To keep pace with trends and regulatory challenges, medical device companies must undergo a digital transformation

Demands of changing compliance regulations

Recent trends among life sciences companies include improving patient outcomes at every stage of the value chain, as well as increasing efficiency and maximizing revenue growth. To achieve this goal, medical technology companies must develop a comprehensive data strategy that meets the demands of changing compliance regulations. Companies must also focus on leveraging data insights and analytics solutions developed specifically for the life sciences industry, such as AI-powered solutions for drug discovery or predictive analytics for payment trends.

In addition, there are increasing security and privacy challenges that life sciences organizations must address. As regulatory requirements continue to evolve, it is important for organizations to adopt stringent security measures to protect sensitive patient data. Organizations should look at solutions such as biometric authentication or multi-factor authorization protocols to ensure secure access control to sensitive data points.

Main challenges

  • Unique Inventory Management Challenges
  • Maintaining Regulatory Compliance
  • Implementing Reporting Best Practices
  • Ensuring Data Security
  • Designing Data Management Policies
  • Contract Lifecycle Management
  • Business Process Automation

Industry Insights

Life Science

As trends in the life sciences industry continue to evolve, so do the challenges for companies looking to innovate in this space. It is important for companies in this field to stay ahead of the trends by proactively developing strategies that allow them to respond quickly and effectively to changes in their industry. By effectively preparing for the challenges and trends within their respective industries, medical technology companies are better equipped to increase efficiencies and maximize revenue growth while improving patient outcomes at every step of the value chain.

By leveraging new technologies and trends, medical technology companies can evolve their business models to meet the challenges of the life sciences industry. Companies must therefore focus on compliance, comprehensive data use, and security measures to drive innovation and revenue growth. With this strategy, it is possible to realize an efficient and commercially successful digital transformation in the life sciences sector.

To keep pace with these trends, medical device companies must undergo a digital transformation that ensures traceability and auditability of product data from product design to delivery of the product to the customer. To realize an efficient and successful digital transformation in the life sciences sector, companies must consider compliance regulations, comprehensive data usage including management, and security measures.

Life Science Industry Solutions

PDSVISION enables end-to-end capabilities and processes for the unification of the engineering, quality and regulatory data for medical device innovators:

  • Implement the best practices for defining and maintaining DHF and DMR for effective and efficient design and document control
  • Streamline the change notice process for UDI submissions for Class-I, II, III devices to FDA / MDR
  • Implement a close loop change and quality processes by unifying the engineering, quality and regulatory world
  • Implement quality to ensure that all customer complaints, audit findings, product and processes non-conformance (NC) are digitally captured and are traceable for closure
  • Implement CAPA processes to ensure corrective actions for existing issues and preventive actions to avoid recurrence
  • Enable training tracking framework to ensure that existing and new users/ employees for the latest releases of forms, procedures and specifications
  • Perform or liaise with external consulting firms for the process validations – Installation, Operations and Performance Qualifications
  • Implement core PLM capabilities like parts, bill of materials (BOM) and manufacturing resources and processes (BOP) to build the digital thread for E2E traceability
  • Perform data migrations since many of our medical devices companies have been very actively involved in merger and acquisitions in the last one decade
  • Build integrations between enterprise applications, especially PLM and ERP for smooth and real time data flow across the enterprise

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Digital transformation is everything. Get it right! Talk to us. Our team is on hand to answer your questions.

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