
- Get in Touch with Us
Last Updated: Apr 26, 2025 | Study Period: 2023-2030
According to the International Medical Device Regulators Forum (IMDRF), "software designed to be utilised for one or more medical purposes that perform these functions without being part of a hardware medical device" is what is meant by the term "software as a medical device."
The Medical Device Regulation (MDR) will be in full effect. The MDR also applies to any software that satisfies the definition of a medical device, in addition to detailed requirements pertaining to physical medical devices.
To handle data, scheduling, and activities, hospitals, medical offices, and healthcare providers use it. It strives to improve efficiency, ensure optimization, and streamline routine tasks all while improving the patient experience as a whole.
Examples of "NOT a SaMD software" are as follows: Mobile applications that promote "soothe and relaxation" and stress management. apps for smartphones that promote healthy living-related behaviours such as weight loss, exercise, and good eating.
Whether software qualifies as a medical device depends on its intended purpose." "Even if your software has a medical function, if software, for example, is intended to communicate, save information, or do a simple search, it does not qualify as a medical device," the statement reads.
The rule is MDR. It outlines WHAT we must accomplish but not HOW we must complete it. Medical equipment in the EU must adhere to the MDR. is typical.
The Global Medical device software market accounted for $XX Billion in 2022 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2023 to 2030.
PolarSeal has created a cutting-edge order-tracking platform for medical device firms wanting to streamline operations and boost productivity to enhance service and communication within the sector.
Customers can trace the development of their purchases with greater accuracy and simplicity thanks to PolarSeal's new order-tracking software. Customers can now obtain the most up-to-date information by viewing real-time updates through a secure web gateway.
Customers may track their orders and stay in touch with one another using this practical platform from any location in the world.
Sl no | Topic |
1 | Market Segmentation |
2 | Scope of the report |
3 | Abbreviations |
4 | Research Methodology |
5 | Executive Summary |
6 | Introduction |
7 | Insights from Industry stakeholders |
8 | Cost breakdown of Product by sub-components and average profit margin |
9 | Disruptive innovation in the Industry |
10 | Technology trends in the Industry |
11 | Consumer trends in the industry |
12 | Recent Production Milestones |
13 | Component Manufacturing in US, EU and China |
14 | COVID-19 impact on overall market |
15 | COVID-19 impact on Production of components |
16 | COVID-19 impact on Point of sale |
17 | Market Segmentation, Dynamics and Forecast by Geography, 2023-2030 |
18 | Market Segmentation, Dynamics and Forecast by Product Type, 2023-2030 |
19 | Market Segmentation, Dynamics and Forecast by Application, 2023-2030 |
20 | Market Segmentation, Dynamics and Forecast by End use, 2023-2030 |
21 | Product installation rate by OEM, 2023 |
22 | Incline/Decline in Average B-2-B selling price in past 5 years |
23 | Competition from substitute products |
24 | Gross margin and average profitability of suppliers |
25 | New product development in past 12 months |
26 | M&A in past 12 months |
27 | Growth strategy of leading players |
28 | Market share of vendors, 2023 |
29 | Company Profiles |
30 | Unmet needs and opportunity for new suppliers |
31 | Conclusion |
32 | Appendix |