FDA Compliance for Product, Quality, and IoT solutions with PTC and USDM Life Sciences

PTC and USDM Life Sciences offer a compliant SaaS solution to address pharmaceutical, medical device, and other sectors supporting the healthcare industry to bring new and enhanced products to market.
PTC’s product development solutions for life sciences companies allow them to develop breakthrough products that save lives and improve medical outcomes. PTC’s lifecycle solutions for medical device, pharmaceutical, and biotechnology innovators provide best in class solutions for product development, quality management, manufacturing, and IoT/connected devices. 
Together, PTC and USDM address the medical device industry’s need for solutions and tools that enable customers to quickly validate Windchill and Thingworx and remain in a validated state, in the cloud, or on-premises.

USDM Cloud Assurance for PTC provides validation for PTC Cloud SaaS solutions, enabling PTC customers to meet FDA’s 21 CFR Part 11 and global computer system validation and computer software assurance requirements.  This solution offers a wealth of competitive advantage in the industry. 

How PTC + USDM can support your business:

  • Implement Quality by Design and enhance global quality processes
  • Enable the use of connected products that meet regulatory requirements and transform the patient experience
  • Utilize a methodology and toolkit successfully audited by regulatory agencies and following FDA’s recent Computer Software Assurance (CSA) recommendations
  • Prepare for EU MDR product submission
  • Significantly reduce implementation and validation time
  • Decrease the cost to manage cloud compliance
  • Accelerate innovation with a platform of compliant-ready solutions

Read our white paper on the benefits of Using PTC's ThingWorx Solution in a GxP Regulated Environment.

PTC + USDM close the loop on product quality, accelerate new product introductions, and ensure continuous compliance.

Contact us today to learn more.

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