Top 10 ERP Needs for Medical Device Manufacturers

Medical device manufacturers operate in one of the world’s most highly regulated industries, which makes the needs for a special manufacturing ERP system even more important. When success hinges on time-to-market, traceability, quality management and compliance with the latest regulatory requirements, a medical device ERP can add loads of value. Whether a company is a venture capital medical device start-up, or a growth-oriented medical device company, each must follow closely controlled processes to develop and manufacture products so they meet the strictest quality standards. Let’s explore the industry obligations and the top factors you should consider in a medical device ERP.

How Healthcare and Medical Device ERP Simplifies Compliance

To fully manage quality and track all data related to products across the entire supply chain, the ERP needs of medical device manufacturers must be met with systems that monitor production, purchasing, documentation, and traceability of products, and do so while cost-effectively managing compliance requirements.

The U.S. Food and Drug Administration (FDA) 21 CFR 820 QMS requirements are in place to ensure product safety and efficacy of medical devices. Good manufacturing practices require medical device manufacturers to apply relevant sections of FDA Part 820 to their operations. This makes an appropriate ERP a critical piece of an overall quality management system for medical devices—one that must be validated for regulatory agencies.

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.

Identifying the Top ERP Needs of Medical Device Companies

To ensure your intended Medical device ERP checks all the boxes, you first need to identify what those boxes are. Here are the top 10 things to look for when evaluating a new ERP system for your organization, such as QAD for life sciences. It should:

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. Provide complete visibility, control and audit trail of manufacturing processes

5. Offer Integrated Corrective Action/Preventive Action (CAPA) functionality

6. Deliver lot and serial tracking and traceability

7. Include warranty and service tracking

8. Ensure regulatory compliance

9. Include supplier management/approved vendors settings

10. Eliminate time-consuming, paper-based tracking systems

Expert Help for Choosing Your Medical Device ERP

Strategic Information Group helps medical device companies leverage QAD ERP for life sciences, and also offers a full range of medical device solutions including ERP, CRM, and QMS. We help venture capital medical device startups commercialize and established companies reach their exit strategies, such as IPO or company sale.

The Strategic team serves medical device manufacturers in the San Francisco Bay Area, Southern California, Boston, and other regions across North America. We help each client 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

Get our free ERP RFP template, designed specifically for the needs of Life Sciences companies by contacting a Strategic representative. Or click here to learn more about life sciences ERP.