SAP Business One for Medical Device Companies

Thrive in a Complex Regulatory Environment with a Unified ERP System

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Rapid advances in medical technology are providing innovative companies with great opportunities to bring a new product to market and companies with established products to evolve. However, the processes by which products can be tested, proven and certified is heavily regulated. Having an ERP solution that supports these processes and has established controls around manufacturing and Supply Chain Management (SCM), can accelerate the time to market and get your product out ahead of the competition.

Whether it’s getting products licensed for sale, creating a strong international presence, making your company an attractive acquisition opportunity, or complying with FDA or other regulatory authorities, you can count on SAP Business One to help you achieve your business goals and stay ahead of the competition.

SAP Business One for Medical Device Companies is a comprehensive ERP solution that has been tailored to the industry-specific needs and regulatory requirements of medical device manufacturers and distributors.

With SAP Business One, medical device manufacturers and distributors can take control of their business, streamline their entire manufacturing and supply chain operations, and allocate resources efficiently as the company grows using a single unified ERP system.

Operator uses medical imaging equipment

Features of SAP Business One for Medical Device Companies

Improve your regulatory compliance, production and inventory control and global distribution capabilities using a trusted application, built for growing medical device companies.

Regulatory Compliance

SAP Business One provides end-to-end control of your manufacturing and supply chain to ensure your products adhere to strict industry regulations; including the FDA.

Full End-to-End Traceability

Support for multilevel serial and lot traceability of components provides complete visibility and proof of compliance with approved designs, suppliers and production methods.

Project Planning and Management

Sophisticated project tools to support your new product introduction (NPI), including cost and production control for prototyping, testing and approval processes for the customer or clinical trials.

Production Control

Once a product is approved for production, SAP Business One allows you to create and maintain multilevel bills of materials (BOMs) containing items, resources (capacity) and text (instructions).

Material Requirements Planning (MRP Planning)

Ensures that production is planned efficiently to meet customer deadlines and components from approved suppliers are ordered and delivered on time.

Variant Management

Efficiently manage product characteristics, locations, and variants so you can serve local and global markets with differing requirements for similar products and meet appropriate regulations for each.

Inventory and Warehouse Controls

Manage inventory in multiple warehouses and locations to meet customer demands in the most efficient and effective way possible, such as FIFO or shelf life. Monitor costs using FIFO, actual by lot/serial, moving average or standard costing.

Real-Time and Pervasive Analytics

On top of hundreds of standard reports, you can create custom dashboards containing queries, reports and analytics with accurate, real-time data. You can also extrapolate historical data into the future to forecast trends and make informed business decisions.

Automated Workflows

Set up various best practice business scenarios and automate administrative processes to save time and money and better concentrate resources where needed.

Quality Control

Fully embedded Quality Control (QC) within all steps of the production process and supply chain to ensure that not only are potential quality control issues detected in real time for correction, but a complete audit of all testing is kept and can be provided immediately against any product.

Integration Capability

Integrate with CAD and PLM machines and devices, nesting solutions, and more.

Customer and Service Management

Anticipate customer demands and have products available for delivery when orders are received. Coordinate and manage all your after-care support and services more efficiently.

Return Material Authorisations

Manage repair and replacement of warranty-controlled parts and products, control and monitor warranty cost, view up-to-date status on incoming units, repair orders and shipping of replacements.

Recall Management

Automate and document the recall process, trace back to original lots/batches, conduct recalls with any information at hand, conduct mock recalls to improve efficiency.

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Top Five Challenges Solved for Growing Businesses in the Medical-Device Industry

Learn how top medical device companies overcome common business challenges with the right technology.

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Benefits of SAP Business One for Medical Device Companies

SAP Business One is proven to help medical device companies support a lean organisation that is agile and flexible from the R&D and NPI phase through to and after product introduction. This system can evolve and grow along with you in the fast-changing medical devices & components sector.

Prove Regulatory Compliance

With a complete audit trail of manufacturing processes

Data Security and Audit Compliance

Keep all records secure and organised for historical reporting and auditing events

Faster Time-to-Market

With streamlined product development and manufacturing processes

Global Localisations and Compatibility

SAP Business One is available in 42 country localisations and 27 languages for quick market expansion

Maximise Inventory Visibility and Controls

Gain real-time and complete visibility and control over products in multiple locations and countries

Reduce Inventory Costs

By automating inventory reporting and forecasting and by preventing ballooning inventory levels

Optimise Resource Allocation

Gain visibility of available capacity to avoid bottlenecks and optimise production plan

Position Your Company for Continued Growth

When all your finance, supply chain, logistics, sales and warehouse data is accessed through one application

“Implementing SAP Business One has helped us bring together finance, supply chain, logistics and warehouse management under one platform and it has really transformed the way we do and run our business.”

Bill Francis
Director Information Technology,
Avinger, Inc.

Meet Strict Industry Standards, Certification Standards & Regulatory Compliance

Use secure, comprehensive documentation and tracing functionality throughout all the development, manufacturing and distribution process to cover these international medical device regulations.

  • FAA, FDA cGMP (Current Good Manufacturing Practice with complete manufacturing documentation)
  • ISO 9000/9001/9002 (Quality System-Model for Quality Assurance)
  • ISO13485 (ISO9001 Biomedical particular standards)
  • EN46001 (European Medical Device for Quality Assurance)
  • 21 CFR Part II (Electronic Records & Signatures) 21CRFII - Secure electronic signature and document control to comply with 21 CFR Part 11
  • (FPLA) Fair Packaging and Labelling Act - Regulatory Labelling requirements for Medical Devices
  • GAAP Certified Finance system with complete audit trail
  • QSR (Medical Device Model for Quality Assurance)
  • RCHSA (The Radiation Control for Health and Safety Act) – section 358H – manufacturers & distributors of radiation-emitting electronic devices to place certification labelling
  • Comprehensive Corrective Action/Preventive Action (CAPA) and Process/Product PQ functionality
  • Canada: Class I Medical Software for safety and effectiveness, labelling, distribution records, mandatory problem reporting, recall requirements
  • UK: NHS Supply chain EDI & NHS Framework Agreement Pricing

How Our Customers Succeed

See how SAP Business One has helped our medical device companies run simple, grow fast and drive profit.

SAP Business One Success Story Crocker Ventures

Contact Us

By implementing SAP Business One for Medical Device Companies as your ERP solution, you can improve your company’s inventory management and regulatory compliance so that you can focus on continuing to grow your business and achieve your goals.

Talk to us now to learn more about SAP Business One for Medical Device companies.

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