FAQs
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What are Electrical Safety Testing's?
These tests should be carried out on all active electrical products. These tests are based on standards EN 60601-1 and EN 60601-1-1. If there exist product-specific standards (codes EN60601-2-XX), they are applicable too. Compliance with all these standards should be taken into account during the design process.
Posted on: Jun 03, 2011
What is Electromagnetic Compatibility?
These tests are intended to assure that the devices emit electromagnetic disturbances within certain limits, and that to a certain degree they are impervious to electromagnetic disturbances from other devices. These tests are based on standards EN 60601-1 and EN 60601-1-2. If product-specific standards exist (codes EN60601-2-XX), they are applicable too. Compliance with all these standards should be taken into account during the design process.
The services of Arazy Group can comprise consulting on EMC whenever tests fail. A specialized engineer will assist you in solving design issues and modify the type unit so that the tests are passed.
Posted on: Mar 15, 2011
How to demonstrate Product Compliance?
For your product to appeal to potential markets, it has to be shown to be safe and effective. While clinical trials, and other types of testing, are aimed at demonstrating the effectiveness of the product, there is a battery of specific tests your product has to undergo in order to assure its safety. These tests should be performed by certified laboratories to prove that the device is safe both for the user and the patient.
In essence, the safety requirements, despite slight technical variations, are valid in all major markets - Europe, the USA and most other countries. The battery of tests applicable for your product will be tailored according to its nature.
In addition, other important issue to assure the safety of your products is the implementation of an adequate labelling process. Arazy Group offers you a review of the labelling executed by our professionals.
Most of these services can be provided by Arazy Group. Selecting and clicking on the proper yellow button you can obtain more information on them.
Posted on: Jun 03, 2011
How can I meet Software Validation requirements?
The number of medical devices which are software-operated is rising sharply in recent years. Malfunction of the software may be life-risking. Therefore, software validation tests have become most demanding. The tests employed in Europe or the USA are based on standards issued by the FDA and IEEE (EN60601-1-4).
Every device which incorporates software has to comply with such standards, and present documentation of six steps. Testing procedure is very thorough, and includes the following steps:
Hazard/risk analysis document.
Software Requirements Specifications (SRS) document.
Software Test Plan, and Software Test Procedure Specification document
Software Test Reporting form.
Summary of test results.
Software quality assurance plan, and configuration management plan
Software validation projects can be an excellent training tool for your own software engineers, who can learn how to produce the required documents for future software projects.
Posted on: Mar 15, 2011
What is Biocompatibility used for?
Used for testing of products that comes in direct contact with the human body. This test is used to verify that the product is not toxic, and does not cause allergic reactions. These tests are based on the ISO 10993 standard.
Posted on: Jun 03, 2011
How does one validate a Medical Device Sterilization?
These tests are designed to verify that the product is microbe and virus-free. These tests also assure that the product's shelf-life is not compromised by its packaging. The standards employed are the EN550, EN552, and EN554. The four most frequently used sterilization techniques are:
Sterilization using Gamma rays
Gamma rays disrupt chemical bonds and disrupt the reproductive capability of viruses and bacteria.
Sterilization using Ethylene Oxide
This process is used on products that disintegrate with radiation. It is a lengthy and toxic process. When completed, specific verification tests must be performed to assure that no poisonous molecules remain on the product.
Heat sterilization
Bacteria and viruses are destroyed in high temperatures exceeding 120°C.
Sterilization using Sidex
This is one of the less popular techniques, used for very delicate instruments (such as endoscopic cameras) that may be damaged by other sterilization methods.
The choice of the proper sterilization process will depend on the materials of which your product is composed.
Posted on: Jun 03, 2011
What is Product Labelling?
Labelling serves to communicate safety and performance related information to users of medical devices and/or patients as well as to identify individual devices. Regulatory Authorities require and specify information that manufacturers are expected to incorporate on the labelling when the device is placed onto the market.
Labelling is a written, printed or graphic matter, affixed to a medical device or any of its containers or wrappers, or accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping.
This matter must be designed according the requirements of national and international standards that are applicable to your product, such as EN980
Arazy Group can advise you in the labelling process to fit all the legal requirements where you sell your products.
Posted on: Jun 06, 2011
What is Canada Health Classification System?
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada, under the Canadian Medical Devices Assessment System (CMDCAS).
The level of regulatory scrutiny to be applied is based on risk management principles that use a rule-based system to classify medical devices into four classes, with Class I representing the lowest risk and Class IV the highest. Here are some examples of devices relating to product classification.
| Description | CE Classification |
| adhesive strip | I |
| amalgam alloy | III |
| aneurysm clips | IV |
| angiographic system X-ray | III |
| angioplasty coronary laser | IV |
| breast implants | IV |
| cerebral blood flow monitor | IV |
| daily wear soft contact lenses | II |
| disposable surgical instruments | II |
| electro anaesthesia apparatus | III |
| endoscopic still camera | I |
Posted on: Jun 06, 2011
What type of QMS should a Medical Device manufacturer implement?
No doubt, obtaining marketing approval for your product is a major achievement. However, this achievement is not sufficient. As developer, manufacturer or distributor of the product, you also have to demonstrate that you possess the capability to maintain high quality procedures. The device you manufacture and distribute today has to be essentially identical in all aspects to the device that you will manufacture 3 years from today. How do you assure such high quality standard?
The answer is simple - the medical device industry, and the medical regulatory authorities, drawing on the vast experience gained during the last decades, have issued sets of quality standards. You need to possess these standards and act upon them right from the early stages of the development, through the entire life-span of the product. Periodic audits by officials of the European, American and other regulatory authorities are aimed to ascertain full compliance with these standards.
Although the basic demands are common, there is no universal standard. You should be equipped with the standards issued or accepted by the authorities of your target market.
The European authorities accept the ISO 9001:2000 and the ISO 13485:2003 quality standards. These standards are valid in each of the European Community countries, and apply in conjunction with the 93/42 EEC Medical Device Directives.
The American regulatory agency, the FDA, has published the Quality System Regulation (QSR) standards.
The Canadian ministry of health has published a Medical Device Regulations document that references the ISO 13485:2003
Other countries might have specific standards, which can be implemented upon request. Look for specific questions on CE QMS Requirements, FDA QMS Requirements, or CMDCAS QMS Requirements.
Posted on: Jun 03, 2011
What are the CE Quality Management System Requirements?
You will need to establish and maintain a Medical Quality Management System compliant with the 93/42 EEC Medical Device Directives.
The European authorities accept the ISO 9001:2000 and the ISO 13485:2003 quality standards as a basis upon which the Medical Quality Management System can be built. However, you should avoid the hassle of reinventing the wheel and use ISO 13485:2003, which is specific of the medical devices industry.
A Notified Body will perform the Medical Quality Management System audit before you are authorized to affix the CE mark on the devices.
The 93/42 EEC Medical Device Directives allows for different scopes of your Medical Quality Management System: full quality system, production quality system, or product quality system. Usually the implementation of a full quality system is the most convenient approach.
Posted on: Jun 03, 2011
