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.
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)
savings in paperwork
Reduce quality control process time 85% by eliminating paperwork and leveraging an electronic device history record (eDHR). (W.L. Gore & Associates)
reduction in time
Save time searching for data with an information management system for full traceability. (iThera Medical)
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
Identify potential problems early in the design and process development stages and reduce risk with a comprehensive Quality Management System (QMS) that ensures full traceability from design development to post-market surveillance.
- Address quality continuously with a comprehensive management system
- Leverage integrated Risk & Requirements management, Failure Modes and Effects Analysis (FMEA) and quality planning
- Ensure a complete Design History File (DHF) and Device Master Record (DMR) for seamless design transfer to production
Manage regulatory interactions throughout the product lifecycle and develop a quality-based culture.
- Improve interactions with health authorities via an intuitive information management system
- Make all required information available with a centralized and customized regulatory information management system (RIMS) powered by integrated data management
- Streamline processes such as preparing and submitting product registrations and handling adverse events reporting
iThera Medical
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.
Explore our resource library
Improve patient safety with an enhanced quality approach and simplified regulatory management, ensuring medical device quality and efficiency.
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