Online Safety Community

An understanding of Risk Management and Analysis for Medical Device Manufacturers


Risk Management and Analysis1.jpghttps://globalcompliancepaneltraining.files.wordpress.com/2018/02/risk-management-and-analysis1.jpg?w=914&h=620 914w, https://globalcompliancepaneltraining.files.wordpress.com/2018/02/r... 150w, https://globalcompliancepaneltraining.files.wordpress.com/2018/02/r... 300w, https://globalcompliancepaneltraining.files.wordpress.com/2018/02/r... 768w" sizes="(max-width: 457px) 100vw, 457px" width="457" height="310" />

Risk management and analysis for medical device manufacturers is an essential set of approaches to quality in the field of medical devices. Implementing these is of absolute importance and criticality to the field, as the products in this industry are high-specialty ones that deal with human lives. A small error at any stage can send the product, and with it, the reputation of the manufacturer and even the healthcare provider, into a tailspin.

From its beginnings a few decades ago as a “nice to have” feature or discipline that used to come into the picture only when there were issues; quality has grown into an indispensable element of a medical device product. A medical device product into which quality does not get intertwined at every stage, right from procurement of the raw material to the use it is put to by the consumer and beyond, is unthinkable today.

risk-management-and-analysis-for-medical-device--manufacturersThe primary driver of this metamorphosis is risk management. Risk management and analysis for medical device manufacturers has been the lynchpin among the agents of change brought about into this field. Quality has evolved as a result of the change in the import regime in the US in the seventies, when products from around the world used to deluge the US market.

the consequences of this trade policy have led to the emergence of the creation of quality approaches such as Six Sigma and kaizen among many others, and global standards, of which ISO 14971 specifically relates to Quality Management Systems and methods for medical devices. Root Cause Analysis is at the root of each of these methodologies and standards.

So, what is risk management and analysis for medical device manufacturers?

risk-management-and-analysis-for-medical-device--manufacturersIn the context of medical devices, risk management and analysis for medical device manufacturers means applying a set of processes, policies, methods and practices into their manufacturing systems in alignment with respective and relevant standards as set out by global standards such as the ISO. The aim of these standards and practices is to analyze, assess, control and monitor risk. The ISO 14971 has been revised many times and each time this is done, the latest one becomes the extant version. This and other standards and practices prescribe steps and processes that need to be implemented at all stages of the product lifecycle.

The need for risk management and analysis for medical device manufacturersThe need for risk management and analysis for medical device manufacturers is simple: To ensure that the medical device meets quality requirements and is manufactured according to standards and specifications and methods prescribed in these standards. Standards such as ISO 13485, various Quality Systems Regulations (QSRs) such as 21 CFR 820 and a few European standards work in tandem with ISO 14971. The core purpose of requiring medical devices manufacturers to meet these requirements is to ensure that safety and quality are built into a medical device from start to finish.

The time at which to carry out risk management and analysis for medical device manufacturers

risk-management-and-analysis-for-medical-device--manufacturersRisk management and analysis for medical device manufacturers is to be carried throughout the lifecycle of the medical device. A set purpose is set out at each stage of the manufacturing process. For example, medical device manufacturers are required to identify and eliminate potential hazards at the initial stage using the concepts of product optimization, and use the principles of risk elimination at all the next stages, and to use the methods prescribed during a product recall.

The ways of carrying out risk management and analysis for medical device manufacturersThe ways by which risk management and analysis for medical device manufacturers are to be exercised form an important part of quality. The ISO 14971 standard is pretty flexible in this regard, allowing the manufacturer to adapt any existing standard or approach that he thinks is best suited for his organization.

Click to Continue Reading

Views: 82

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

MARKET STREET posted a blog post

Personalized Unique Baby Gifts | Unique New Baby Gifts | Market Street

Market Street has a wide range of personalized unique baby gifts. Market Street is a leading online seller of handmade personalized unique baby gifts in Ireland. Buy the best unique baby gifts online from Market Street at a reasonable price.See More
20 hours ago
Mark Nilson posted events
20 hours ago
Training Doyens posted events
yesterday
Cadencealida posted a blog post

Madden 20: How to evaluate the Franchise

With the release of Madden 20, EA provided a new story mode. I must admit that I was very excited when I first saw it and read something about it. It gives gamers the opportunity to experience college football, even a small amount, and also the opportunity to provide a controlled backstory for the players you create. Fast forward to now, the mode has been played several times, and the excitement has weakened. The hopeful start turned into a disappointing end. What do we think of The Face of…See More
yesterday

Forum

Fix Corrupt Sharepoint Database

SharePoint software which is associated with intranet, document management and with content management. But you may get some error and there are numerous reasons for that error. However to repair…Continue

Started by william riley on Thursday.

How do I restore SharePoint?

SharePoint Server recovery software is quite famous in today’s organizations and this is…Continue

Started by william riley on Thursday.

Recover outlook pst 2 Replies

The process of Outlook PST Recovery is not an easy task to do and the user can lose its data if it…Continue

Tags: emails, repair, outlook, recovery, pst

Started by william webb. Last reply by Kassia on Wednesday.

EDB to PST converter 2 Replies

Get help of this EDB to PST Converter software which can convert Exchange Server EDB files into MSG and EML…Continue

Tags: migrate, edbtopst, pst, to, edb

Started by william webb. Last reply by Sunil Sharma on Wednesday.

Quickly convert EDB to PST 1 Reply

Try this EDB to PST converter software which is well developed and has advanced features which…Continue

Tags: convert, pst, to, edb

Started by bradly anderson. Last reply by Sunil Sharma on Wednesday.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service