Medical and precision manufacturing industry requires manufacturers to produce high quality medical products using specialized equipment, materials and packaging. At the same time, they have to ensure efficient operations, just in time delivery, low production, material and overhead costs. Apart from this, they have to comply with stringent TS13485 & ISO 9001 standards and meet U.S. Food and Drug Administration (FDA) requirements right from product planning till customer delivery. In order to be consistently efficient in their manufacturing operations and achieve growth, manufacturers would need a robust ERP software that will help them, 

  • Automate their manufacturing workflows & operating processes
  • Build accurate, detailed quotation & cost estimates
  • Maintain detailed product documentation & revision control
  • Maintain audit trail of manufacturing processes
  • Track & maintain employee certifications
  • Track products throughout the supply chain
  • Track warranty details & service schedules
  • Comply to stringent TS13485 & ISO 9001 standards & FDA requirements

Let us look at how Medical Equipment manufacturers can achieve this with the help of an ERP software. 

Quality & Compliance

Quality management is one of the most critical processes for medical equipment manufacturers. They have to comply with stringent TS13485, ISO 9001 standards and FDA requirements. Which means, various quality parameters will have to be in-built into their manufacturing workflows. This includes data automation, robust documentation and monitoring tools that track manufacturing processes at every stage of production for quality anomalies. 

Any dip in quality parameters or failure to adhere to quality standards results in heavy penalties, and even revocation of manufacturing license for the manufacturer. 

With an ERP software’s advanced quality management module, manufacturers can,

  • Track non-conformance data through a centralized database that is integrated with RMA, Shop Floor transactions & inventory.
  • Get advanced material traceability from cradle to grave along with quality specifications, serial genealogy and controls for FDA CFR 11 and ISO3845. 
  • Analyze quality metrics for suppliers, parts, manufacturing, and operations using advanced quality management dashboards.
  • Assign tasks, generate automatic emails/reminders, and document corrective & preventive action using 8D methodology.
  • Maintain user-defined list of specifications a part should meet, their target values and tolerances.
  • Complete visibility of quality parameters at every manufacturing stage owing to integration with Manufacturing, CRM, CAPA, Finance & Accounting modules.

Material Traceability & Product Serialization

In the medical and life sciences industry, product traceability plays a crucial role and each lot has to be serialized and tracked right from its inception till delivery. An ERP software’s capability to integrate with various tracking tools and technologies helps manufacturers to, 

  • Track products right from procurement till dispatch, serial genealogy, and controls for FDA, CFR 11 and ISO3845. 
  • Track real-time inflow & outflow of inventory and gain greater visibility of the entire supply chain.
  • Trace the origin of a specific part/unit/entire product batch located within the supply chain.
  • Maintain lot items using Barcode Scanner and Auto Inventory Transfer (Bar Code).
  • Track heat numbers, material composition data and attach mill certificates to lot numbers.
  • Integrate with shipping modules for online shipment initiation and tracking. 

Employee Training & Certification

Medical industry witnesses changes in terms of technology, regulations and processes frequently. For manufacturers to keep up with these changes and ensure their products meet industry and regulation requirements, manufacturing employees need to be equipped with the latest knowledge. 

Therefore, employee training and certification acts as a key process in medical equipment manufacturing. An ERP software is equipped to, 

  • Document employee details such as educational qualification, certifications and work-experience for specific tasks.
  • Maintain in-house training records of employees and track certification progress for each of them.
  • Track training expiration, and automatically generate alerts for new training requirements based on revision control on specific processes.
  • Track eligibility requirements for individual processes and link qualified employees.
  • Auto-generate production schedules based on employee eligibility.

Audit Trial & Data Security

Frequent audits in compliance with FDA requires manufacturers to maintain robust documentation and logs. Also, data security is an important aspect as manufacturers have to maintain a tight control over medical formulations, material composition, documentation and customer details. 

An ERP ensures,

  • Comprehensive change logs with time and date stamps per employee/department.  
  • Audit trail, log management and documentation for FDA audits.
  • Analyze transaction level detail for all orders, equipment specifications, financial numbers etc.
  • Track changes to actual field data over a period of time.
  • Data encryption to prevent data leakage and misuse. 
  • Electronic signature capability and password security for secured transactions by authorized personnel. 

Manufacturing Automation

Medical equipment manufacturers have to manufacture complex products, parts, and sub assemblies that require advanced design and BOM management. All this is not possible without manufacturing automation. 

An ERP software plays a key role in bringing in automation by helping manufacturers to,

  • Easily handle complex product designs and requirements with comprehensive multi-level BOMs. 
  • Accommodate frequent changes to BOMs and instantly transfer them to work orders.


Quick and effective distribution of goods is important for medical equipment manufacturers. With an ERP’s in-built CRM and integration capability with various shipping modules, manufacturers can,

  • Manage their distributor, end-user data and their day to day communication with them in CRM.
  • Provide self-service capability and items reorder using partner portals.
  • Manage and maintain multiple warehouses and track inventory movements between them.
  • Maintain shipment information and track each shipment from inception till delivery.


With an ERP software, medical equipment manufacturers can bring in operational efficiency, quality control, manufacturing agility and tighten the leash on production + overhead costs.

We, at OmegaCube understand the unique requirements of Medical Equipment Manufacturers. Our flagship ERP software, OmegaCube ERP meets their unique needs, automates critical workflows and manufacturing processes, and helps them increase their efficiency.