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Medical device digital thread

Medical device compliance

Effectively balance quality and compliance in MedTech through an integrated and collaborative digital framework. Track all quality data for products and processes, ensure quality data continuity and facilitate transparency to stakeholders.

How can I achieve medical device compliance faster?

Empower your teams with digital tools that consolidate quality data across all company departments to continuously master and monitor regulatory compliance and procedures. Deploy an integrated digital framework for quality and compliance, ensuring operational efficiency and establishing information transparency.

Revolutionize your medical device compliance process

Ensure quality and compliance are in sync. Implement an integrated digital system, a comprehensive medical device quality management system (QMS) and an intuitive regulatory information management system (RIMS) to enhance product quality and improve interactions with authorities.

65%

of progressive companies use PLM

Several leading companies have implemented product lifecycle management (PLM) systems for over a year to bolster their digital transformation initiatives. (Lifecycle Insights)

85%

savings in paperwork

Reduce quality control process time 85% by eliminating paperwork and leveraging an electronic device history record (eDHR). (W.L. Gore & Associates)

65%

reduction in time

Save time searching for data with an information management system for full traceability. (iThera Medical)

Medical device solutions

Create innovative and compliant medical devices

Discover how a closed-loop quality and compliance solution can benefit the MedTech industry. Elevate compliance, enhance quality and streamline regulatory processes in an agile process and receive peace of mind with comprehensive, up-to-date results.

Explore these three key paths to learn more.

Utilize digital tools that centralize quality data from all company departments to continuously master and monitor compliance with regulations and procedures.

  • Track quality and compliance data with an integrated digital backbone
  • Automate the flow of documents and data to provide benefits over traditional paper processes including international access
  • Coordinate multi-disciplinary teams and establish metrics to measure the effectiveness of quality processes
Case Study

iThera Medical

Case Study

Boosting engineering information management efficiency reduces time spent hunting for data by over 65 percent

Company:iThera Medical

Industry:Medical devices & pharmaceuticals

Location:Munich, Germany

Siemens Software:Polarion

Using Polarion ALM, we were able to provide the auditor with stringent, robust technical documentation with full searchability and traceability. Due to the auditproof presentability of all required information, the audits were successfully completed online.
Ingmar Thiemann, VP, Quality Management and Regulatory Affairs, iThera Medical
Medical device compliance & quality

Explore our resource library

Improve patient safety with an enhanced quality approach and simplified regulatory management, ensuring medical device quality and efficiency.

Four co-workers looking at a laptop screen with one pointing at the monitor.

Achieve compliance via a closed-loop solution

Product lifecycle management

Manufacturing execution management

Application lifecycle management

Compliance & sustainability management

Quality management

Frequently asked questions

A quality management system (QMS) is a structured framework used to oversee and manage the quality of products and processes in an organization. It involves planning, controlling and monitoring activities related to product design, development, manufacturing and post-market surveillance. A QMS aims to ensure product quality, regulatory compliance and continuous improvement by integrating data, automating workflows and facilitating collaboration across departments. It helps companies streamline compliance, enhance efficiency and maintain high standards of product safety and performance.

A regulatory information management system (RIMS) is a centralized and customized system that integrates data management to streamline regulatory processes, manage regulatory interactions and ensure information transparency within a company. It helps track and manage all regulatory data throughout the product lifecycle, facilitates compliance with regulatory requirements and supports efficient preparation and submission of product registrations and reports. RIMS enhances collaboration, enforces data accuracy and accelerates product releases by automating regulatory affairs activities and providing easy access to required information for internal and external stakeholders.

Achieving regulatory compliance during medical device development requires a holistic approach where quality and compliance complement each other. This can be done in a two-step process. The first is implementing a quality management system (QMS) that accelerates product development and reduces time-to-market. The second step is using an integrated digital platform, such as product lifecycle management (PLM), that simplifies and enhances the simultaneous management of multiple regulatory requirements. This connectivity accelerates compliance for market submissions and supports the continual quality improvement of your medical devices.

There are three stages of regulatory compliance. The first stage is establishing a digital quality and compliance framework by utilizing a QMS within a PLM system to track quality data for products and processes. The second stage is streamlining quality data continuity and feedback by leveraging QMS capabilities for integrated risk management, failure mode analysis and quality planning. The third stage is facilitating transparency to internal and external stakeholders using RIMS to collect data across lifecycle phases. By aligning RIMS with business processes, you enable collaboration and easy access to essential information while improving communication with health authorities.

Managing quality assurance in medical device manufacturing involves a comprehensive approach to ensure product safety and compliance. Key strategies include:

  • Early identification of potential problems during the design and process development stages.
  • Utilization of tools like Risk & Requirements management, Failure Modes and Effects Analysis (FMEA), quality planning and ensuring full traceability from design development to post-market surveillance.
  • Continuous improvement through complaint management, Corrective Action Preventive Action (CAPA) process and change management.

As the medical device industry is heavily regulated, there are various standards and regulatory requirements that are applied simultaneously. A QMS enables you to leverage integrated Risk & Requirements management, Failure Modes and Effects Analysis (FMEA) and quality planning. It helps ensure full traceability of design development phases for a complete Design History File/Device Manufacturing Record (DHF/DMR) and seamless design transfer to production, ensuring enhancement of quality processes during each manufacturing execution step. Implementation of QMS will also enable you to verify and confirm that all employees are cyclically trained and certified according to expected requirements.

Learn more

Read

Ebook | Elevate quality management in medical device product development

White paper | Efficient medical device delivery with a closed-loop quality management system

Solution brief | Refine process validation for design transparency

Read

Infographic | Unlock the power of medical device quality management

Fact Sheet | Digitize the product development process with Teamcenter

Ebook | Enhance regulatory information transparency for medical devices

Watch

Video | Quality Management for Medical Devices

Video | Join quality management with compliance for medical device safety

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