Life Sciences

License to Cure – An industry solution experience for Medical devices – 

Given the sharp rise in the development of complex mechatronic medical devices, combination products, digital health devices, coupled with ever growing regulatory and quality constraints, in order to ensure the delivery of safe efficacious products, the medical device industry is undergoing a digital collaborative transformation in an effort to accelerate the delivery of high quality, novel life-saving medical products at lower costs. 

 Accelerate the delivery of innovative, safe and fully compliant medical devices through a full life-cycle solution that covers end-to-end traceability of design controls to make regulatory compliance easy by incorporating key filing documents such as Design History File (DHF), Device Master Record (DMR), Corrective And Preventive Actions (CAPA), and system requirement traceability matrix.  Siloed teams are a thing of yesterday as competitive and high-performing  teams choose to collaborate throughout the entire life of a device.

Medical Device designers can bring your Excel BOM or CAD from SOLIDWORKS, CATIA, or most CAD systems to create and validate manufacturing production plans, quality assurance plans, operations, and everything you need to complete your device master record as you go. Instead of working in silo teams, make collaboration the core strength of your business

New England area is one of biggest epicenters of innovation in medical devices (including active and passive implantable medical devices), digital health, and healthcare.  They acquire some of the top research hospitals in the country, which in 2018, secured thousands of NIH awards totaling some $2.89 billion according to a Grant Thornton report prepared for the trade group MassMEDIC.  According to grant Thornton, Massachusetts leads on PMA and 510(k) clearances with medical devices, being nearly a quarter of Massachusetts’ exports involving medical devices. 

Get ready for 510(K) or Pre Market Authorization (PMA) by making compliance a cultural shift

Being ready for 510(k) submissions and PMA filings, companies must provide an electronic copy of their submission. 

The lead reviewer will need to clear it before you receive marketing clearance. This means, that the lead reviewer for your 510(k) or PMA application will need review that your design controls and design outputs satisfy your design inputs. They need to see that your requirements are traceable all the way through to your design solution. In addition, any approvals, signatures, or design reviews should be able to easily navigate through your DHF and DMR. Including compliance teams early in the life cycle will enable you to be prepared not only when you need to be, but throughout the entire project.

Highlights of the Industry Solution:

  • Reduce errors and non-compliance risks by being up to date with the latest versions of design changes so that when the time comes to create your DHF and DMR, you're only working with the latest version. 

  • Quickly and accurately compare changes to the DHF and DMR based on the latest updates and versions to CAD models, MBOMs, and process plans. 

  • Always be aware of and work with the latest versions of requirements, design inputs, design outputs, review comments, and V&V criteria. 

  • Track approvals, design reviews, and CAPA through a collaborative single digital thread with a 21 CFR Part 11 compliance standard for electronic signatures. 

  • Import CAD from SOLIDWORKS, CATIA, or any CAD system to seamlessly create your EBOM, MBOM, manufacturing production plans, quality assurance plans and V&V plans in preparation for your Device Master Record. 

  • Leverage Modelling & Simulation to see how your devices will behave through interaction with surgeons and doctors. 

Find out how you can use the single digital thread on the 3DEXPERIENCE platform to accelerate your devices to market. 

 ENGINEERING  |  MANUFACTURING  |  SIMULATION  |  IMPLEMENTATION

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