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Compliance4all
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  • Fremont, CA
  • United States
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Compliance4all posted a blog post

What does the medical device/biotechnology auditor look for and why?

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.Apart from going by these guidelines; the auditor also uses her intuition and observation gained from personal experiences to…See More
Jun 14
Compliance4all posted a blog post

Food Fraud in the Organic Industry

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the organic…See More
Jun 5
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Jun 5
Compliance4all posted events
Apr 9
Elisabeth Berman liked Compliance4all's profile
Mar 15
Compliance4all posted events
Mar 9
Compliance4all posted a blog post

When a medical device fails to meet these standards for precision and accuracy

All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.Although the FDA has medical device calibration requirements, many of these medical devices do not have specific measures that need to be set. So, in view of this, the FDA can only require that the core quality needed for the…See More
Feb 27
Compliance4all 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
Feb 23
Compliance4all 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
Feb 20
Compliance4all 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
Compliance4all 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
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Feb 12
Compliance4all 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
Compliance4all 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
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Jan 23

Profile Information

Area of Expertise or Interest?
Compliance4All has experts who share a wealth of knowledge covering best practices in industry. These trainings help participants refresh their knowledge about regulatory compliance. Our panel of Experts imparts learning on a number of areas relating to compliance, such as:

Medical Devices
Pharmaceutical
Food
PCI industries, and
SOX

Our webinars cover the following Governing Areas:

FDA
GxP (Manufacturing/Clinical/Lab)
CMDR
EU
ISO
SOX and
PCI

These are the functional areas Experts from Compliance4All offer their expertise on:

Regulatory
Clinical Trials, and
Quality
Type of Affiliation?
Academia or NonProfit
Years of Experience in MedTech Field
10
About Me
Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.
Professional Objectives
Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.

Compliance4all's Blog

What does the medical device/biotechnology auditor look for and why?

Posted on June 14, 2018 at 7:18am 0 Comments

Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.

Apart from going by these guidelines; the auditor…

Continue

Food Fraud in the Organic Industry

Posted on June 5, 2018 at 5:47am 0 Comments

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.

This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the…

Continue

When a medical device fails to meet these standards for precision and accuracy

Posted on February 27, 2018 at 4:58am 0 Comments

All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.

Although the FDA has medical device calibration requirements, many of these medical devices do not have specific measures that need to be set. So, in view of this, the FDA can only require that the…

Continue

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

Posted on February 23, 2018 at 5:39am 0 Comments

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

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At 8:47am on February 17, 2016, FRANK KWABENA said…

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