How These New Medical Device Standards Could Affect You

Author: Trinity M Consulting, LLC. | | Categories: Clinical Research Consulting Services , Medical Device Consulting Firm , Medical Writing Services


As professionals in the medical device industry, it’s essential to stay up to date with the latest tools, trends, and technologies to keep our clients ahead of the curve. The latest changes we want to bring to the attention of medical device stakeholders’ are the new standards released by the U.S. Food and Drug Administration department.

It includes Computer Software Assurance for Production and Quality Systems. It also provides Software Draft Guidance for Industry and Food and Drug Administration Staff. Read on to learn more.

II. Background

43 - FDA envisions a future state where the medical device ecosystem is inherently focused on device

44 - features and manufacturing practices that promote product quality and patient safety. FDA has

45 - sought to identify and promote successful manufacturing practices and help device

46 - manufacturers raise their manufacturing quality level. In doing so, one goal is to help

47 - manufacturers produce high-quality medical devices that align with the laws and regulations

48 - implemented by FDA. Compliance with the Quality System regulation, Part 820, is required for

49 - manufacturers of finished medical devices to the extent they engage in operations to which Part

50 - 820 applies. The Quality System regulation includes requirements for medical device

51 - manufacturers to develop, conduct, control, and monitor production processes to ensure that a

52 - device conforms to its specifications (21 CFR 820.70, Production and Process Controls),

53 - including requirements for manufacturers to validate computer software used as part of

54 - production or the quality system for its intended use (see 21 CFR 820.70(i)).4 Recommending

55 - best practices should promote product quality and patient safety and correlate to higher-quality

56 - outcomes. This draft guidance addresses practices relating to computers and automated data

57 - processing systems used as part of production or the quality system.

59 - In recent years, advances in manufacturing technologies, including the adoption of automation,

60 - robotics, simulation, and other digital capabilities have allowed manufacturers to reduce sources

61 - of error, optimize resources and minimize patient risk. FDA recognizes the potential for these

62 - technologies to provide significant benefits for enhancing the quality, availability, and safety of

63 - medical devices, and has undertaken several efforts to help foster the adoption and use of such

64 - echnologies.

66 - Specifically, FDA has engaged with stakeholders via the Medical Device Innovation Consortium

67 - (MDIC), site visits to medical device manufacturers, and benchmarking efforts with other

68 - industries (e.g., automotive, consumer electronics) to keep abreast of the latest technologies and

69 - to better understand stakeholders’ challenges and opportunities for further advancement. As part

70 - of these ongoing efforts, medical device manufacturers, have expressed a desire for greater clarity

71 - regarding the Agency’s expectations for software validation for computers and automated data

72 - processing systems used as part of production or the quality system. Given the rapidly changing

72 iii  - Available at

72 iv This guidance discusses the “intended use” of computer software used as part of production or the quality system (see 21 CFR 820.70(i)), which is different from the intended use of the device itself (see 21 CFR 801.4).

72 v- Contains Nonbinding Recommendations Draft – Not for Implementation

73 - nature of software, manufacturers, have also expressed a desire for a more iterative, agile

74 - approach for validation of computer software used as part of production or the quality system.

Please click on the link for more information:

Get in touch with us today!

If you require assistance with medical devices, contact Trinity M Consulting, LLC. As an experienced medical device consulting firm in Florida, we will help you by rendering a fast, customized, and specialized service.

Our services include regulatory affairs consulting, project management consulting, clinical research consulting, quality systems consulting, and talent recruitment consulting.

To learn more about the other services we have to offer, please click here. If you have any questions about medical device standards, please call (888) 537-3906 or email us at