be_ixf;ym_202001 d_21; ct_50

3 Pain Points for Medical Device Manufacturers on Regulatory Compliance

Here are three of the major regulatory compliance pain points for medical device manufacturers, and how a modern ERP solution can address them

Medical device manufacturers must balance finite product life cycles with strict regulatory requirements that are closer to those in more formula-driven sectors than standard discrete manufacturing obligations. Lean production helps ensure ROI, yet processes must be streamlined without jeopardizing compliance procedures. A tendency to rely on subcontractors to maintain speed and cost-effectiveness compounds the existing worries of human error causing noncompliance.

Ensuring regulations are being adhered to throughout the production line can be time-consuming, yet not complying with consumer protections will not only create repercussions from regulatory agencies, but also from any users of defective products. To maintain both compliance and a lean production cycle, manufacturers of medical devices require a modern technology solution to alleviate their extensive time and labor costs.

Modern enterprise resource planning (ERP) software enables medical device companies to address potential bottlenecks efficiently. By providing an overview of operations data and allowing for automation of otherwise manual processes, ERP solutions mitigate production obstacles.

Here are three of the major regulatory compliance pain points for medical device manufacturers, and how a modern ERP solution can address them:


Corrective and preventative actions (CAPA) are a group of protocols established by the FDA as a guideline to identify and record all possible issues with a potentially hazardous product, and steps to protect against consumer harm before and after distribution of said product. Implementation of CAPAs provides a guideline for manufacturers to minimize customer exposure to dangerous items.

CAPAs represent both the proactive and reactive methods of addressing a product suspected of being defective required of manufacturers by 21CFR820.100 (Subpart J of Part 820). FDA inspections are thorough in identifying proper CAPA adherence, or lack thereof. If the latter is found, the agency will issue a warning with a deadline for corrective steps to be completed.

Manually fulfilling CAPA requirements is laborious and time-consuming. The list of obligatory tasks as dictated by the FDA is extensive, creating a bigger risk for human error to lead to noncompliance. A modern software solution alleviates this danger with compliance automation features and an integrated, easily accessible central database.

ERP systems with CAPA add-on solutions compile all the necessary information into one infrastructure for easier availability. This allows CAPAs to be planned, delegated, and carried out much more quickly than if relying on manual procedures and traditional communication methods. Task and workflow automation also enable more efficient scheduling for CAPAs, and a leaner production cycle overall.

2. Product Tracking & Traceability

At their discretion, the FDA may order a medical device manufacturer to produce the history of a product from its creation to its distribution. This establishes that the manufacturer has a tracing system in place that can accurately follow a product to its destination. Medical device tracking is used in the event that a device has shown signs of potentially affecting patient health adversely, so that the item can be monitored.

The tracking order may include any Class II or Class III medical device, though it most often targets those that can be potentially dangerous to personal health, implanted in the human body for over a year, or life-supporting devices. The initial deadline for the order is usually 10 days, except in certain circumstances, and new audits must be carried out every six months afterward for the first three years. Tracking only ends after the device in question is returned or destroyed, or the patient it was meant for passes, and tracking systems can be subject to FDA inspections.

Medical device tracking represents a serious consideration for compliance maintenance that can be extremely time-consuming. It requires manufacturers to remain in contact with all elements of their product’s distribution channel, which mandates diverting resources to monitor operations outside of the organization. Without an accessible digital tracking system, these tasks will stall supply chain processes further.

Part 821 allows manufacturers to track devices by their lot number, batch number, model number, or serial number. Modern ERP systems with workflow control and traceability allow you to monitor and record all this data within the system. Product information is meticulously catalogued and can be quickly accessed to identify packages on demand. Audit trails provide you with a roadmap to product delivery points in the event of a medical device tracking order.

3. Medical Device Reporting

Medical Device Reporting (MDR), or Part 803, is a regulation that affects medical device manufacturers, facilities that use medical devices, and importers of medical devices. It requires members of all three groups to establish an identification and reporting system for deaths that may have been caused by a medical device they handled at some point. Reporting is mandatory for manufacturers, as MDR helps to determine whether a medical device product is potentially hazardous to the public.

Manufacturers do not initially have to admit any fault on their part if a device appears to malfunction, and in fact can indicate such in their report. However, they must still record and submit all information related to the event, such as the personal details of the patient or patients affected by the device. The FDA will conduct their own investigation to determine whether the product was responsible, but the onus remains on the manufacturer to compile and maintain of all the data that can absolve or implicate them.

MDR is another compliance requirement that can burden supply chain processes with additional procedures. Without an up-to-date technology solution, manufacturers would be forced to manually file and track down all the pertinent information. Cataloging that much data by hand would be incredibly time-consuming and increase the risk of a mistake being made by personnel.

Comprehensive ERP suites with integrated central databases provide greater access to historical data for review. Extensive reporting allows you to examine the history of any product, and assists you in identifying any possible faults its manufacturing. Modern ERP also contain better security measures against defective products being distributed, including requiring multiple signatures at several junctions before distribution and the ability to flag items. This helps in narrowing faulty medical devices that did not pass these checks.

To read more about how Enterprise Management (formerly Sage X3) can help medical equipment manufacturers, check out this success story here


Sage X3 is a Modern ERP Solution That Can Better Handle Compliance

Modern ERP products like Sage X3 have built-in functionality for managing tedious regulation compliance procedures. They enable you to keep your production cycle and business streamlined, and alleviate manufacturing downtimes that can result from breaches of compliance. To read more about how X3 can help medical equipment manufacturers, check out this success story here.

Want to know more?

SWK Technologies, Inc.