Medical device manufacturers operate in one of the world’s most highly regulated industries, where success can hinge on time-to-market, traceability, quality management and compliance with the latest regulatory requirements. Whether a company is a venture capital medical device start-up (VC medical device start-up) or a growth-oriented medical device company, it must follow closely controlled processes to develop and manufacture products that meet the strictest quality standards.

In order to fully manage quality and track all data related to all of their products across the entire supply chain, medical device manufacturers need ERP systems that monitor production, purchasing, documentation and traceability — while cost-effectively managing compliance requirements.

An appropriate medical device ERP is a critical piece of an overall quality management system for medical devices (medical device QMS) that must be validated for regulatory agencies. U.S. Food and Drug Administration (FDA) 21 CFR 820 QMS requirements ensure product safety and efficacy. Good manufacturing practice (GMP) requires medical device manufacturers to apply relevant sections of FDA Part 820.

Medical device ERP software should help companies meet all FDA requirements for both software and operations. Manufacturers should look for comprehensive compliance monitoring, quality management (QM) and supply chain management functionalities.

The Top 10 things to look for when evaluating a new medical devices ERP system, such as QAD for life sciences, include:

  1. Ensure quality standards compliance such as TS13485 and ISO 9001
  2. Meet FDA software validation requirements
  3. Secure electronic signature and document control to comply with 21 CFR Part 11
  4. Complete visibility, control and audit trail of manufacturing processes
  5. Integrated Corrective Action/Preventive Action (CAPA) functionality
  6. Lot and serial tracking and traceability
  7. Warranty and service tracking
  8. Regulatory Compliance
  9. Supplier management/approved vendors
  10. Eliminate time-consuming, paper-based tracking systems

ERP Solutions for Life Sciences Strategic Information Group helps medical device companies leverage QAD ERP for life sciences, along with a full range of medical device solutions including ERP, CRM, and QMS. We help VC medical device startups commercialize and established companies reach their exit strategies, such as IPO or medical device company sale.

We serve medical device manufacturers in the Bay Area, Southern California, Boston and other regions across North America to help them meet the critical needs of Life Sciences manufacturers:

  • Fully integrated business processes, including: Manufacturing, Financials, Quality, CAPA, CRM
  • Support for GMP, SOX, FDA Regulations and FDA Software Validation
  • Device and Batch History Reports and support for FDA audits/recalls
  • Cradle-to-grave traceability, serial genealogy and controls for FDA CFR 11 and ISO3845
  • Flexible and affordable deployment options including Cloud ERP and mobile access via iPad, iPhone, Android

Contact us today about our free ERP RFP template designed for the needs of Life Sciences companies.