Resource Directory

Compliance4All being a comprehensive portal for all the areas of regulatory compliance, its resource directory is a treasure house of insights and knowledge on any of the areas of regulatory compliance, regulations and best practices that one can think of. Compliance4All's resource directory is a fountainhead for knowledge that helps regulatory compliance professionals all the perceptiveness needed for excelling in their profession. It goes a considerable distance in helping them meet the demands set by regulatory agencies around the world, while also helping them structure their business processes and improve the bottom line.


Medical Device:

The role of regulation in the field of medical devices is critical. The role medical devices play in ensuring the safety of patients is incalculable. Medical devices have to go through extremely stringent processes in manufacturing, marketing and usage, while meeting regulatory compliance requirements at every stage and in every way. Compliance4All's resource directory offers substantial knowledge of regulations and standards in this field, such as ISO 14971, ISO 13485, DHF, IEC 62304, 510 (K), Computer system validation, Quality System Regulations (QSR), etc.


Biocompatibility testing and evaluations for medical devices

Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient's body has to not only perform its intended purpose and function it should also not result in adverse reactions for the patient. more...


The ISO 13485 - an Understanding

The ISO 13485 is the current standard for medical devices. The set of standards it prescribes are to be implemented by manufacturers of medical devices. The ISO 13485, expanded to ISO 13485: 2003 to denote the year in which it came into existence; is the management standard the ISO has set to ensure that medical devices meet the prescribed quality standards. ISO 13485 is independent and is a standard in itself; yet it is harmonized with ISO 9001, for which it takes off, and is often implemented alongside the 9001. more...


Lyophilization Technology -a Brief Understanding

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. more...


The FDA's Medical Device Calibration Requirements

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. more...


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 fatal. more...


Understanding Medical Device inspection

A medical device inspection is one of the most important activities the FDA carries out to determine that a device meets the requisite regulatory standards for ensuring safety and effectiveness. It is a core GMP activity and hence covers all medical devices ranging from the smallest to complex ones such as MRI's. more...


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 "[e]ach manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. more...


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. more...


The 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 controls are put in place to ensure that the manufacturer is able to locate an error at any stage and take remedial steps. more...


Advanced Process Control is Rooted in Regulatory Process Control

Organizations in any industry involving process control have to implement advanced process control mechanisms for maximizing return on investment (ROI). Maximization of ROI being a very important objective of any industry involving plant management; the key to realizing this is putting the right regulatory process control in place. No external activity, such as buying the most sophisticated control equipment or loading systems with the most advanced software is going to be of any use unless the organization gets its regulatory process control right. more...


Risk management and ISO 14971

The ISO 14971 is a global standard in the realm of risk management. Its regulations and guidelines are meant for software used in medical devices. Regulation of software in medical devices is critical because it is software that powers the medical device. All the intended use functions of the medical device are performed entirely because of its software. Keeping this in mind, the ISO formulated the ISO 14971 standard, into which risk management inheres. more...


Process validation for 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 do this. more...


A look at the principles of FDA requirements for medical devices

The FDA has some clear-cut requirements that those manufacturing medical devices have to meet in order to get their products approved. FDA requirements for medical devices cover regulations for these devices, based on the way they are classified, and for meeting set regulatory guidelines. more...


The FDA steps up efforts at bringing about medical device cyber security

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cyber security is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them. more...

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