Medical Device QMS & Compliance FAQs

How does Sparta help medical device companies manage risk?

Medical device companies face a number of challenges: more regulations, shorter product life cycles, and the need to increase operational efficiency. Managing compliance and assuring consistent quality are nearly impossible utilizing manual and paper-based systems to manage processes.

Sparta helps medical device companies reduce risk, increase efficiency, and lower costs while speeding up quality and compliance.  Easily comply with 21 CFR Part 11, 21 CFR Part 820, GMP, ISO13485, ISO9000, and others regulations. 

Additionally, your quality management processes can be extended out to suppliers, contract manufacturers, and other partners in the external supplier network.  You'll have greater visibility and across your supply chain, helping you to achieve more consistent quality.

How can Sparta help with UDI compliance?

The FDA has laid out requirements for unique device identification (UDI). The next compliance date is September 2018 for Class I medical devices. By 2027, all classes of medical devices will require a UDI label. The sooner organizations adhere to these regulations, the sooner they will be able to enjoy greater traceability and improved visibility across the supply chain.

This is where an automated solution can help. Sparta is used by the 9 out of 10 leading medical device companies to track electronic regulatory submissions. The solution enables users to package 25 required fields and send them to FDA’s GUDID through XML transport and delivery. When the gateway receives the transmission, it will send back an acknowledgement, which is tracked as part of the workflow. Any changes made are done through the change control process, providing a compliant and risk-free solution for regulations.

Does Sparta support ISO 13485 certification and other regulations?

Yes, it supports ISO 13485 certification and is compliant with a number of different regulatory standards, making it an optimal solution for medical device companies looking to maintain quality. Other regulatory standards supported include 21 CFR Part 11, 21 CFR Part 820, ISO9000, ISO13488, ISO14001, ISO14791; EN 46001 and 46002; GMP #40 and #63.

How does Sparta help medical device companies with supplier quality management?

With an estimated valuation of more than $23 billion, there's no question that the medical device outsourcing industry is huge. Quality control and creating standardized processes are necessary, but can be difficult to implement. This is where supplier quality management (SQM) software can help. Sparta SQM software allows medical device manufacturers to measure and support their suppliers with scorecards, workflows, and nonconformance tracking. And ensures quality management processes are part of a seamless and integrated system.

What are the benefits of Sparta product registration tracking for medical devices?

Automating your product registration tracking is essential to improving productivity and cutting costs. Product registration tracking can help you lessen risk and remain compliant with ever-changing global regulatory standards. Other key features include:

  • One centralized location that supports integration with other quality and compliance processes.
  • Automatic monitoring of all regulatory activities.
  • Point and click configuration for changes to global regulations.
  • Quick search and report generation for needed information.
  • Configurable field to manage data.

Does Sparta work with other Medical Device companies?

Yes, 13 out of the top 15 medical companies have chosen Sparta QMS and compliance software. Sparta has over 750,000 global users, and Sparta Systems has had more than 700 successful software implementations in over 30 different countries.

How does Sparta manage complaint handling and adverse event report?

When medical device manufacturers receive complaints regarding products, they must adhere to reporting requirements set by the FDA. As part of complaint management, manufacturers must identify and monitor adverse events (deaths, serious injuries and malfunctions) involving medical devices and adhere to reporting requirements set by the FDA’s Medical Device Reporting (MDR) regulations.

Having an integrated global complaint management system in place allows medical device manufacturers to comply with the FDA and other regulators. Effective August 2015, electronic submission of medical device records (MDRs) are now required by FDA to help with the gathering and analyzing post market MDRs while minimizing data entry errors.

The ability for a complaint handling system to recognize if a product issue is widespread is the first step to implementing corrective and preventative actions, and increasing patient safety.

 

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