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Adam Fleaming
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  • Fremont, CA
  • United States
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Latest Activity

Adam Fleaming posted a blog post

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even…See More
Friday
Adam Fleaming posted a blog post

Florida capital to press for gun law change

A hundred Stoneman Douglas High School students are busing 400 miles to Florida’s capital Tuesday to urge lawmakers to act to prevent a repeat of the massacre that killed 17 students and faculty last week.The students plan to hold a rally Wednesday in hopes that it will put pressure on the state’s Republican-controlled Legislature to consider a sweeping package of gun-control laws, something some GOP lawmakers said Monday they would consider. Shortly after the shooting, several legislative…See More
Tuesday
Adam Fleaming posted a blog post

FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…See More
Feb 16
Adam Fleaming posted events
Feb 15
Adam Fleaming posted a blog post

Medical Device Process Validation is the Key Part of a Quality Process

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.The FDA standard for medical device process…See More
Feb 14
Adam Fleaming posted a blog post

FDA’s requirements on medical device product development process

One of the most elaborate prescriptions that the FDA has relates to the medical device product development process. This is because any error at any stage of the medical device product development process can result in serious repercussions for the patient. Since nothing is to be left to chance, the FDA has a series of steps in the medical device product development process. These are aimed at ensuring that there is total control of the device from the earliest to the last stage. All these…See More
Feb 12
Adam Fleaming posted a blog post

Medical Devices is aimed at ensuring very high quality assurance standards

Process validation for medical devices is a key ingredient of quality assurance in medical devices. Process validation is the criterion for measuring the effectiveness of a quality system for medical devices. The first step that medical device manufacturers have to take to show compliance with regulatory requirements for new and modified existing medical devices is obtaining premarket approvals (PMA) and premarket notifications. Process validation for medical devices is the step that helps them…See More
Feb 6
Adam Fleaming posted a blog post

CISOs map out their cybersecurity plan for 2018

When Omar F. Khawaja compiled his priority list for 2018, he didn’t include which security technologies he wanted or how many IT staff he hoped to hire.Instead, the CISO at Highmark Health — a healthcare management and insurance provider whose portfolio includes Allegheny Health Network, United Concordia Dental and Visionworks, among others — articulated an overarching strategy on how the cybersecurity plan should fit within the national organization’s business…See More
Feb 2
Adam Fleaming posted a blog post

What is the purpose of lyophilization & Where it will be applied?

Lyophilization is the clinical term for freeze-drying. In the simplest terms, it can be described as a technical process in which the moisture level of many materials is reduced, most times frozen, for the purpose of creating a new product or an ingredient.When an injectable drug is freeze-dried -this is the process of lyophilization -its compounds are stabilized. This reconstitution process is helpful and…See More
Jan 25
Adam Fleaming posted a blog post

Food Production Is A Modern Agricultural Miracle So Why Is It Under Attack

Agriculture is under attack. Environmentalists label modern farming as unsustainable, blaming farming for polluting the planet and destroying the climate. But today’s food is abundant and nutritious—a modern agricultural miracle.From 1961 to 2013, world population more than doubled from 3.1 to 7.2 billion. But agricultural output more than tripled over the same period, according to data from the United Nations.…See More
Jan 24
Adam Fleaming posted blog posts
Jan 23
Adam Fleaming posted blog posts
Jan 19
Adam Fleaming posted events
Jan 19
Adam Fleaming posted blog posts
Jan 17
Adam Fleaming posted a blog post

Telehealth Gives Rural Missouri More Access to Health Care

ST. ROBERT, Mo. (AP) — With a population just shy of 5,000, the town of St. Robert lies just south of the heart of Missouri. It’s one of the many rural towns in the state that finds alternatives to health care access through the internet.Since the early 1990s, the telehealth network has helped connect patients to health care providers from their own homes. Increasing technology has made the service more efficient, with live audio…See More
Jan 12
Adam Fleaming posted blog posts
Jan 11

Profile Information

Where do you live (city, state, country)?
NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
What industry do you work in?
compliance4all
What is your job title?
Event Coordinater
What company do you work for or associate with?
compliance4all
Do you currently use or recommend Personal Protective Equipment?
Yes
How did you find our online community?
through google
What best describes the role you play in the purchase of safety products?
Specify what hand protection to purchase, Use hand protection on my job, Make the actual glove purchases from a supplier, Other
If Other above, please explain.
it is very usefull

Adam Fleaming's Blog

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be…

Continue

Posted on February 23, 2018 at 5:38am

Florida capital to press for gun law change

A hundred Stoneman Douglas High School students are busing 400 miles to Florida’s capital Tuesday to urge lawmakers to act to prevent a repeat of the massacre that killed 17 students and faculty last week.

The students plan to hold a rally Wednesday in hopes that it will put pressure on the state’s Republican-controlled Legislature to consider a sweeping package of gun-control laws, something some GOP lawmakers said Monday they would consider. Shortly after the shooting, several…

Continue

Posted on February 20, 2018 at 5:02am

FDA regulation on medical device packaging design

The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…

Continue

Posted on February 16, 2018 at 4:48am

Medical Device Process Validation is the Key Part of a Quality Process

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.

The FDA…

Continue

Posted on February 14, 2018 at 5:03am

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Latest Activity

nicolewells posted a discussion

Security Storage SAN Performance

Hello All,Have a question regarding SAN performance specifically EMC VNX SAN. I have a significant number of processes spread over number of blade servers running concurrently. The number of processes is typically around 200. Each process loads 2 small files from storage, one 3KB one 30KB. There are millions (20) of files to be processed. The processes are running on Windows Server on VMWare. The way this was originally…See More
yesterday
Rebecca Lewis posted a discussion

What safety signs should I acquire for my shop’s construction?

Hello everyone! The construction of my new flower shop will start next month, and it’s a big project for me. Since the shop’s location is near the main road, I want to make sure that everyone is safe during the work. I can’t afford any accident like people getting injured. So I’m thinking of purchasing construction health and safety signs from a supplier that my friend recommended.…See More
Friday
Rebecca Lewis joined Safety Community's group
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Construction

For those working in Carpentry, Drywall, Electric, General Labor, HVAC, Landscaping, Masonry and Plumbing.
Friday
Adam Fleaming posted a blog post

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even…See More
Friday

Forum

Security Storage SAN Performance

Hello All,Have a question regarding SAN performance specifically EMC VNX SAN. I have a significant number of processes…Continue

Tags: san, vmware, emc

Started by nicolewells yesterday.

What safety signs should I acquire for my shop’s construction?

Hello everyone! The construction of my new flower shop will start next month, and it’s a big project for me. Since the shop’s location is near the main road, I want to make sure that everyone is safe…Continue

Started by Rebecca Lewis on Friday.

Gig Economy

The career world has rapidly changed and these days, long-term careers and people working in just one job are slowly but steadily becoming a thing of the past. In fact, according to research, in the…Continue

Tags: field, engineer, IT, freelance, economy

Started by Mohd Azher on Wednesday.

How to Repair MySQL InnoDB Table That Has Issues?

When trying to run: delete IdentityRequest *I get an error of sailpoint.tools.GeneralException: null index column for collection: sailpoint.object.IdentityRequest.itemsDoing a select * from…Continue

Tags: course, sailpointonline, sailpoint

Started by Soujanya Naganuri on Tuesday.

Occupational Health and Safety 7 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tony Ferraro Feb 18.

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