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How to Manage Business Complexities in Medical Device Manufacturing Industry

Medical device manufacturing industry, being one of the most crucial and life-saving industries in the world is largely affected by economic downturns, population demographics, and technological advancements. It deals with a huge range of components such as hypodermic needles, syringes, implanted defibrillators, female diagnostics and other cardiac monitoring equipment – to name a few.

Undoubtedly, this sector will evolve by leaps and bounds in the coming years – considering the increasing health concerns and rising population. Thus, medical device manufacturers are striving hard to undertake new technological solutions at a rapid speed.


Despite the evolving technology and changing trend, medical equipment manufacturers should take necessary steps pertaining the product quality. Let’s have a look at the following challenges faced by this industry–

  1. Ensuring regulatory compliance – Stringent regulations, traceability and safety and the major concerns for a medical device manufacturer. As the compliance and regulatory standards vary from country to country, garnering government support in the form of tax and financial support, subsidized research and development etc. are a few regulatory challenges faced by manufacturers.
  2. Product quality – To minimize product recalls and customer dissatisfaction, product quality is paramount. FDA regulated medical device manufacturing industry aims to compile every piece of information in order to meet the growing demand and government norms. Using a full-fledged software, businesses can track devices by their batch number, lot number or serial number- it can systematize every process and minimize product recalls.
  3. Inept business processes – Managing every product, operation and resource of a business is not a piece of cake. Medical device manufacturing industry should be backed by a state-of-the-art technological tool that can facilitate cross-functional automation, seamless data sharing and mobile access to the files and documents. A software that breaks down silos and supports operations such as warehouse management, production, procurement, quality control, shipping and other basic functions will undeniably promote better decision-making and time management.


The benefits of ERP cannot be stated in a set of words – it’s far beyond that. From textile industry to telecommunication and medical device manufacturing, almost every industry today invests in an industry-leading ERP software that can integrate every part of the business into one and simplify the complex manufacturing processes.

An ERP software can handle all the business operations by offering an array of business intelligence tools and intuitive dashboards. It lets you meet the industry-specific requirements by attaching, creating and co-authoring the important files from remote locations. Enterprise resource planning software is a set of business management tools that optimize order planning and fulfillment, handles underutilized inventory, stock-outs, ensures better quality standards, BOM management and looks after almost every area of a manufacturing unit.

⦁ Its user-friendly dashboards and easy to use functionalities ensure that even a non-techy person can learn its ropes

⦁ The full-fledged solution brings every function under one umbrella and consolidates business data in a single screen

⦁ Ensures that every medical appliance designed on the shop floor meets the stringent regulatory norms

⦁ Real-time visibility of data promotes coordination and smoothens inter-departmental relations

⦁ Offers modules for production, quality, supply chain, HR, accounting, sales, finance, costing, reporting, outlook integration, CRM, MRP, purchasing, business partner management

Medical device manufacturing sector is vast and so are its functions. From SMBs to globally acclaimed companies such as Johnson & Johnson, every manufacturer strives hard to stand out in this market.

This is how ERP can help medical device manufacturers to evolve in this ever-evolving market:

⦁ Compliance – Medical device industry is driven by a long list of strict regulations, compliance items and standards given by the authorities. Medical device manufacturing organizations place more emphasis on sharing data within the organization than on empowering customers to participate in the process. This is primarily due to stringent compliance, safety, and liability considerations.

⦁ Manufacturing automation – Nobody in this modern world is relied on paper forms, sheets and repetitive manual processes of creating invoices or other documents. With the growing technology, ERP solution has taken over the manual processes and eliminated data redundancies. ERP automates day-to-day accounting tasks such as maintaining journal entries, supporting tax calculations, production processes, auto-generate quality control orders.

Order fulfillment – From point of sales inquiry to delivery of the products to customers, every process should be streamlined in order to avoid stock-outs and lower inventory returns. ERP software acts as a central hub where you get the information about procured and shipped products, purchase order and inventory. It helps all the departments to work proactively – order planning, fulfillment information is cascaded on time, managers work rigorously on timely delivery performance, everyone ends up doing a better job.

⦁ Real-time tracking – Fortunately, there are some ERP softwares that offers the functionality of automating serial and lot tracking as per the production (along with traceability). It allows you to plan for multi-level, double-level, single-level sampling and 100% inspection of products. It also streamlines the processes by offering features such as batch and serial number tracking to support your QC operations.

OptiProERP with SAP Business One is a reliable and affordable ERP solution for small and mid-sized manufacturers. It facilitates real-time visibility into Supply Chain, checks the quality of every medical equipment while being procured, received, shipped, stored in inventory or final assembly. OptiProERP with SAP Business One also helps manufacturers facilitate regulations and standards by offering features such as AQL (Accepted Quality Level) and RQL (Rejected Quality Level) – this lets you adhere to the stringent quality norms.

Please feel free to contact us to know more about how ERP for medical device manufacturers can help you execute your plans and achieve the given target in a medical device manufacturing industry. You can also send an email –

Download this whitepaper on An Overview of Medical Device Manufacturing Industry if you wish to learn more about Medical Device Manufacturing ERP Software and how it can help your medical device manufacturing business with its functions