The Need for Standardization, Especially in ISO 13485 Medical Devices

The first step in achieving permission to sell high quality medical devices in the European Union is in ISO 13485 Medical Devices standard certification. An extremely advantageous service to use is that of an ISO 13485 consultant who can help you define the regulations, identify and analyze the appropriate measures that need to be taken for your business, and advise on implementation and training to maintain those standards. But why is there a basic need for international standardization in the first place? Why is it important for countries all over the world to conform to these standards?

Well, the ISO pertains to many industrial and commercial areas for a reason. We take for granted how many tools or systems we use that translate across countries. Punching holes into paper is one example. The ISO determined the exact diameter for those holes, the exact location of the holes from the margin and established three standards for hole punching: one internationally, one for North America, and one for Sweden. And now we most likely never come across a piece of paper whose holes don’t line up with the rings of a binder, and we never imagine that we could.

Of course, with the ISO 13485 for medical devices, the standardization for tools becomes much more vital. An incorrect hole punch is inconvenient, but not detrimental. It’s important for different countries to all maintain one standard for their medical devices, whatever they may be – instruments, implants, or machines. Otherwise, if different countries had different standards, there could be very serious and harmful results. Besides the obvious critical reasons, it’s also logical in a business sense. With certification, manufacturers can choose to take their companies international, as they are now able meeting the standards expected across the world.

And the ISO doesn’t just work with standardizing tools, there are regulations set in place that universally establish country codes, safety labels, standard atmosphere, programming language and hundreds more. While we live in a world that appreciates diversity in culture by enjoying the foods, clothing, and specialties of different countries, there are a lot of times where it makes sense to all speak the same language and have the same requirements. Medical devices are one very important case. To speak with an experienced ISO 13485 Medical Devices Standard consultant on how to plan and implement procedures to attain certification, contact David Owen Associates.

Ensure ISO 13485 Medical Devices Compliance, Improve Efficiency and Increase Profits

Retaining the services of an ISO 13485 Medical Devices consultant will help your company meet the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

Since implementation of the ISO 13485 standards in 2003, compliance with these standards has come to be seen as a fundamental first step in ensuring the medical devices you manufacture or developing are in compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted in the European Union.

David Owens & Associates are proficient in ensuring that your company will be able to meet ISO 13485 Medical Devices compliance requirements, and in assisting you develop ISO 9000 business management systems. Our goal is to assist you in raising standards, improving efficiency and increasing profits.

Benefits of Working with an ISO 13485 Medical Devices Consultant

Working with a qualified and experienced ISO 13485 Medical Devices consultant assures:

• Development and implementation of a quality management system for your company's medical devices;
• Maintenance of your company's medical device quality management system;
• Development of quality management systems documents;
• Preparation of a quality management system manual;
• Consistent medical device quality management system documents: and
  
• Maintenance of all required quality management system records for medical devices.
  

David Owen & Associates bring a wide range and wealth of experience to every project in providing clients with training for ISO 13485 Medical Devices compliance requirements and developing ISO 9000 business management systems.

ISO 13485 Medical Devices Standards Compliance a "Business Critical Issue" for Manufacturers and Patients Alike

The ISO 13485 Medical Devices standard, like other "ISO Standards" set by the International Standards Organization ("ISO") is a set of manufacturing standards and procedures guidelines that assure quality in the manufacturing and service industries - in this instance, in the manufacturing of medical implements and devices. Working with an ISO 13485 Medical Devices standards consultant is a business critical issue for companies and entrepeneurs entering or engaged in the manufacture and provision of medical devices.

While ISO standards were initially used almost strictly by large companies, increasingly companies large and small have to ensure that they are in compliance with ISO standards and procedures if they wish to bid on contracts, sell their wares or - heaven forbid - defend themselves against product liability suits.

In perhaps no other sector is ensuring ISO compliance more essential than in the manufacture of medical devices for the health services sector. While the quality of the manufacturing procedures and processes behind the production of engine parts for the ambulance that brings a patient to the hospital are unlikely to come into question and turn out to be business critical - although they will be, if the part manufacturer wishes to sell auto parts to Volvo, Mercedes, or whomever the ambulance manufacturer is - compliance with the ISO 13485 Medical Devices standard will be critical for a supplier who wishes to stock that ambulance with the monitors, drips and guerney which will ensure the patient arrives, and arrives safely, at the hospital. (Rule Number One in the medical profession is still, "Do no harm!")

Manufacturers and distributors of medical devices, if acting with prudence, will ensure that they are working with an ISO consultant who is fully versed and has a depth of experience setting up and ensuring ISO 13485 Medical Devices standards compliance. In the health services and medical professions ISO compliance is a business critical issue for all involved - particularly the patient!