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Medical QMS Software Market: Information by Type (Cloud-based, Web-based), Application (SMEs, Large Enterprises), and Region — Forecast Till 2026

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Report Description

The medical device manufacturing industry is subject to a variety of regulations, which are generally stringent in the U.S. and Europe. Medical QMS software helps in diversifying medical device manufacturing and making it more efficient. Further, the software helps in lowering operational costs while offering quality products, which is spurring the growth of the medical QMS software market.

The global medical QMS software market is expected to grow at a CAGR of 8.8% during the forecast period, 2019–2026.

Technological Advancements & Shift in Consumer Expectations

The advancement of technology has been an enabler of growth and innovation for many industries and is poised to do the same for the medical devices industry. In the current scenario, consumer expectations continue to rise in terms of quality and patient care, and, at the same time, resources continue to shrink. As a result, hospitals are shifting from traditional approaches to new and efficient technologies and software that help them enhance quality and performance, which, in turn, is widening the scope for medical QMS software.

The Need to Curtail Healthcare Costs & Medical Errors Drives the Adoption of Medical QMS Software

Performance enhancements are essential to attain safer care as the healthcare industry shifts to a value-based system. The National Institute of Health (NIH) estimates the medical error costs of a preventable nature in the sector at approx. USD 17–29 billion per year. To reduce such avoidable costs and ensure quality, several healthcare institutions are adopting open-source software packages from vendors across the globe. For instance, SunnyBrook Health Sciences Centre, Canada, required a tool that would accurately collect information, track progress, promote the fast turnaround of priority issues, and report data. For years, the company relied on excel spreadsheets; however, the hospital later adopted patient feedback software to monitor its activities. The shift helped in effectively reducing the preventable costs incurred.

Data Security – A Key Concern Associated With Use of Medical QMS Software

Increasing connectivity to existing computer networks has exposed medical devices and software to several cybersecurity vulnerabilities. This is a result of the technological advancements taking place in healthcare delivery, which have the capability and capacity to improve patient care. Regulatory bodies such as the U.S. Department of Health and Human Services & the U.S. Food and Drug Administration take responsibility for assuring the effectiveness, safety, and security of medical devices and thus, monitor data security and other aspects to formulate solutions that mitigate such concerns.

Favorable Regulatory Scenario to Present an Opportunity for the Medical QMS Software Market

The healthcare sector is dynamically driven towards value-based systems and software to ensure quality. Regulatory bodies are also working towards bringing in quality performance in the sector by integrating standards and guidelines and drafting regulations and policies in an attempt to mandate value systems. For instance, the ISO 9001:2015 demands institutions to demonstrate their ability to consistently offer products and services that meet customer and applicable statutory and regulatory requirements. Such initiatives, regulations, and policies that focus on developing medical devices and services keeping in mind the current need for quality among customers, offer an array of opportunities for the medical QMS software market. For instance, the introduction of HL7 QRDA-III STU R2.1 Guidelines and ICD 10 is expected to impart to growth momentum in the U.S. market.

Intended Audience

  • Distributors and Suppliers
  • Healthcare Providers
  • Medical Device Manufacturers
  • Research Institutes and Academic Centers
  • Contract Research Organizations (CROs)
  • Government Associations
  • Market Research and Consulting

Large Enterprises to Account for a Larger Share of the Pie in Terms of Application

SMEs and large enterprises alike adopt medical QMS software solutions. Medical device manufacturers are multibillion-dollar industries consolidated in large organizations. Siemens Healthcare (Revenue: USD 15.4 billion – 2018) and Medtronic (Revenue: USD 30 billion – 2018) are among the key players in the market. Large medical device manufacturers are scaling up their market share through mergers with and the acquisition of small and medium organizations. For instance, Medtronic acquired HeartWare International Inc., Crospon, Mazor Robotics and Nutrino Health Ltd, and Titan Spine in 2016, 2017, 2018, and 2019, respectively. Overall, growth in the manufacturing of medical devices is providing a fillip to the demand for medical QMS software from large enterprises.

Cloud-Based Technologies to Remain Ahead of Web-Based Technologies in Years to Come

Medical device manufacturers are embracing cloud-based technologies due to the increasing pressure on healthcare providers to lower costs and improve patient care. Cloud-based quality management software solutions are cheaper than on-premise solutions; they are interoperable, quicker to install, and associated with low maintenance costs. Medical devices manufacturers gain substantial profits from adopting cloud platforms as they reduce maintenance costs without compromising quality or service. The Obamacare Act (Patient Protection and Affordable Care Act (PPACA) was enacted in the U.S. in 2010; the act mandates more efficient supply chains in healthcare by reducing reimbursements for large hospitals. Furthermore, various medical QMS software providers are collaborating with cloud platform providers to incorporate quality, security, and data integrity.

North America to Remain the Most Prominent Region in Terms of Value Share

North America holds the largest share of the global medical QMS software market, with the U.S. as a prominent contributor in the regional market. The country, with its large geriatric population, has a long track record of chronic diseases. In 2010, under the Patient Protection and Affordable Care Act, the previously uninsured population gained access to healthcare services. The upsurge in the demand for healthcare services is accelerating the need for cost-effective medical devices, which in turn is bolstering the growth of the medical QMS software market in the country.

Europe to Hold the Second Largest Market Share, With Impetus From a Growing Geriatric Population

Europe holds the second-largest share in the global medical QMS software market. The region constitutes a large geriatric population, which is increasing the demand for healthcare services. According to Johnson & Johnson, “People above the age of 65 years use approximately seven times more healthcare-related products and services than younger people”. The growing demand for healthcare services is accelerating the growth of the medical manufacturing industry, and subsequently, accelerating the demand for medical QMS software solutions.

The number of SMEs in medical devices manufacturing is more in Europe. For instance, according to MedTech Europe, there are approximately 27,000 medical technology companies in Europe, and small and medium-sized companies constitute 95% of the medical technology industry in the region. Germany holds a 28% share in medical device manufacturing and the country has the largest number of SMEs.

Asia-Pacific to Remain a Manufacturing/Sourcing Base for Many Global Medical Device Manufacturers

Asia-Pacific is known for manufacturing low-end medical device products such as drainage bags, surgical tape, and rubber gloves, as well as sophisticated class III medical devices such as drug-eluting stents. Due to relatively low labor costs, low overhead costs, and improving technical capabilities, many international medical device companies prefer to source or manufacture their devices in the Asia-Pacific region. For instance, in 2011, Medtronic opened a new manufacturing facility in Singapore, and in 2018, Siemens Healthineers opened a diagnostics manufacturing facility in Gujarat, India.

While labor cost is increasing in China, it remains relatively low in Vietnam, India, and Indonesia; therefore, the sourcing and manufacturing business in these countries is growing. Additionally, in Asia-Pacific’s medical device industry, innovative domestic companies challenge multinational competitors at the higher end of not just regional, but global markets.

LAMEA Pegged to be a Promising Market With Untapped Opportunities

The Middle Eastern countries are some of the world’s wealthiest economies in the world, offering unique opportunities to multinational companies operating in the medical devices manufacturing sector. These players are surging the demand for medical QMS software solutions in the region. On the other hand, the medical devices market in Africa is price-sensitive, exhibiting opportunities for lower-end devices with low costs.

Key Players

Some of the prominent players in the global medical QMS software market are Greenlight Guru, Qualio, CEBOS, InSilicoTrials, QmsWrapper, Qualsys, Sparta Systems, Almond, Siemens PLM, IQS, Inc., MasterControl, and AssurX.

Medical QMS Software Market Segmentation

By Type

  • Cloud-based
  • Web-based

By Application

  • SMEs
  • Large enterprise

By Region

North America

  • U.S.
  • Canada
  • Mexico


  • U.K.
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe


  • China
  • India
  • Japan
  • South Korea
  • Australia
  • Rest of Asia-Pacific


  • Brazil
  • Saudi Arabia
  • South Africa
  • Rest of LAMEA

Frequently Asked Questions (FAQs)

The global Medical QMS Software Market was expected to grow at a CAGR of 8.8% during the forecast period, 2019–2026.
Cloud-based on basis of Type segments is expected to be leading segments in Medical QMS Software Market during the forecast period.
North America is expected to hold the highest market share in Medical QMS Software Market.
Greenlight Guru, Qualio, CEBOS, InSilicoTrials, QmsWrapper, Qualsys, Sparta Systems are the top players in Medical QMS Software Market.

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