Medical Device FAQs

How Can Sparta Systems’ EQMS Address Internal and External Risks Facing Medical Device Companies?

The medical device industry faces a number of challenges. Increased regulations, a shorter product lifecycle, and the growing need to do more with less. Managing compliance and assuring consistent quality are nearly impossible utilizing antiquated manual processes and paper-based systems. Sparta Systems software was developed to help companies in highly regulated industries accomplish their business goals without sacrificing on compliance and quality.

Sparta’s EQMS helps organizations reduce risk, increase efficiency and lower overall cost. It allows organizations to meet the requirements laid out in regulatory standards, including 21 CFR Part 11, 21 CFR Part 820, GMP, ISO13485, and ISO9000. Additionally, when combined with Stratas Supplier Collaboration solution , the quality management processes can be extended out to suppliers, contract manufactures and other partners in the external supplier network. Stratas streamlines quality-related interactions between customers and their partners, giving greater visibility, management and control into an organization’s quality management processes across the global supply chain.

We're Not UDI-Compliant Yet. How can Sparta Systems help get us there?

FDA has laid out requirements in regards to unique device identification (UDI). The next compliance date is September 2018 for Class I medical devices. By 2027, all classes of medical devices will required 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.

Still, implementation isn't easy. This is where an automated solution from Sparta Systems can help tremendously. Sparta Systems’ EQMS is used by the 9 out of 10 leading medical device companies to track electronic regulatory submissions. The eReporting 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 the regulations.

Does Sparta Systems EQMS Support ISO 13485 Certification? Does It Facilitate Compliance with Other Regulatory Standards?

Yes, Sparta’s EQMS does support 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.

We're Planning on Outsourcing More. What Are Some Features of Sparta Systems’ Supplier Quality Management Software that Relate to the Medical Device Industry?

With an estimated valuation of more than $23 billion, there's no question that the medical device outsourcing industry is huge. However, this does not mean that there aren't challenges with outsourcing. First and foremost, there is the issue of quality control and creating standardized processes to ensure the highest level of manufacturing. This is where Sparta’s supplier quality management software can help.

Sparta Systems SQM solution allows medical device manufacturers to measure and support their suppliers through supplier scorecards, supplier quality workflows, and nonconformance tracking. When combined with the rich capabilities of Sparta’s EQMS, Stratas connects manufacturers with suppliers on a cloud-based system, so communications, reports, and workflows can be posted in real-time on a centralized dashboard.

What Benefits Can I Expect with a Product Registration System for Medical Devices?

Automating your product registration tracking is essential to improving productivity and cutting costs. Product registration tracking software can also help an organization lessen risk and remain compliant with ever-changing global regulatory standards. Sparta Systems’ product registration tracking software enables medical device companies to experience these and many more benefits. Here are some features that make Sparta Systems stand out as a top product registration software solution:

  • 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 Systems Have Experience Working with Companies in the Medical Device Industry?

Yes, 13 out of the top 15 medical companies have chosen Sparta Systems for EQMS implementation. Sparta Systems’ EQMS 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 Systems EQMS 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 then communicate with the quality management system is essential for identifying if other facilities are having issues, notifying leadership for continuous improvement and trending to prevent additional problems from occurring in the future therefore increasing patient safety.

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