Importance of Medical Devices in Malaysia

Numerous medical devices in Malaysia are engineered to battle diverse aspects of ailment in humans. Diseases may result from known or unknown causes and are characterized by any hindrance of or deviation from normal body functions of structure. Such devices are vigorously used to detect, treat, examine and avoid disease. In terms of anatomical issues relating to the body’s structure, medical devices are used to investigate, assist, replace or modify issues and structures. The simplest example of a medical device would be the use of a thermometer to assist with diagnosis.

Innovative medical device solutions have helped product development, manufacturing and much more. Medical device technologies are often used for a variety of medical purposes such as therapy, surgery and diagnosing.

Challenges of Medical Device Service Industry

Specific challenges are there which medical device industry have been facing. And meeting those challenges are essential to serve medical device manufacturers completely.

The worldwide market for service providers serving the medical consultation needs has been found increasing in five years. They help in getting the small and large devices registered belonging to categories like Imaging and Navigation systems, Combination Devices, Diagnostic Software Energy emitting technology, Diabetic Products, Surgical Disposables and much more. In serving the manufacturers, the medical device service providers face several challenges which will be discussed in this article.

Workflow management

The kind of work, done by whom and in what sequence is something which come under the workflow management. Different departments and members are specified for different kinds of work related to medical device services. The problem may occur due to any obstruction in any department. Different stages of devices’ lifecycle need to g through different kinds of services. It is Important to deal different phases of devices like composition, quality, size, purpose, etc.

Technical assistance

Different kinds of technical staff and experts look after different technical aspects of the devices. Moreover, the technical assistance team is also comprised of experts like clinical researchers and quality assurance managers to deal the specific aspect. They have multi-disciplinary knowledge to check different effectiveness and quality aspects of the devices. With the help of enough quality assurance experience, they manage to check out technical aspects of the devices successfully. They go through multi-stage interview process to declare the effectiveness and safety level of devices in medical industry.

Compliance and regulatory issues

Different formalities are needed to be fulfilled to make sure the devices are ideal to get authorized by regulatory bodies. Moreover, it is essential to mention the right category, purpose, effectiveness, working principle, quality, composition and much more. Without actual information and quality test reports, it is complicated for medical device service providers to receive authorization of regulatory bodies.

Regulatory strategy for most advanced and complex devices will be found different with the firms and thus the firms work in the way to get the authorization easily after fulfilling all formalities.

From the above discussions, it can be said that all the challenges like workflow management, technical assistance and regulatory issues are needed to meet properly to serve the medical device manufacturers with authorization and market approvals for small or large devices on time.

Arazy Group, a leading medical device service provider comes with professional Medical Device consultants work for validation, verification and regulation processes of devices meant for medical industry. The company is located in Vancouver, BC and has been serving clientele in more than 53 countries.

Significant Role of Medical Device CE Marking Consultants

For selling any medical device or IVD within Europe, it is extremely significant to place a CE Mark on it. Here comes the role of medical CE Marking consultants into picture. 

 

The word CE is derived from the abbreviation of French Phrase” “Conformité Européene” that means “European Conformity”. In short, CE Marking is a sign of conformity to the relevant Essential Health & Safety Requirements that are defined within the European Directives. 

For a medical device manufacturer to launch any medical device or IVD within Europe, it is extremely important to place a CE Marking on it. CE Mark is neither a quality mark nor it is intended for customers. It is just a legalized statement given by the manufacturer that the medical device products or devices that it is planning to launch have fulfilled virtually all the requirements necessary for launch.

Before placing the CE Marking on a medical device or IVD, medical device companies or manufacturers need to do the following:

•    The first and the foremost requirement for placing CE Mark is the compilation of a medical device CE Marking technical file along with proof of compliance to the Medical Devices Directive.  

•    The second major requirement is to receive a medical device CE marked certificate from a notified organization. But this is not required for all. Medical devices are majorly divided into classes including class I, IIa, IIb and III. As far as the IVDs are concerned, these are divided into four categories including General IVDs, list B, self-diagnostics and list A. All the devices except class I and General IVDs are in need of a certificate from a notified organization as well as the implementation of a quality management system, generally lined up with ISO 13485. 

•    For those who don’t have physical location in Europe, it becomes essential to appoint a European Authorized Representative. 

•    Last but not the least; get the medical devices registered with the EU Competent Authorities, where suitable.

 

These are some of the key considerations required for a successful launch a medical product or device within Europe. From the above discussion, it becomes clear that all medical devices have to be CE-marked before entering any of the countries in the EU. 

To achieve better results in this regard, medical device manufacturers require support of CE Marking consultants. There are many experienced consultants that have been working in the direction to provide customers with the best possible results in this regard. Always make sure that you choose the one that is reliable and experienced in marketing safe and efficient medical technology in the international markets.

Know about Medical Device Consultants Team

What do you know about medical device consultants? And which kind of team they come boasted with to serve the clients for medical device registration in different countries?

Medical device consultants come with global regulatory solutions to serve different sized medical device producing companies. The main purpose of the consultants is to help the clients in various product development stages. 

Talking about medical device consultants’ team, they make registration of medical devices successful with the help of a powerful team which is comprised of scientists, regulatory specialists, medical experts, quality assurance managers and clinical researchers. They all work together to let the clients get needed registration for medical devices in less time. 

In this article, we’ll come to know the role of medical device consultants’ team which is active these days in the market. 

Scientists

Different medical devices come with different business plans, product data, preclinical as well as clinical data. And before analyzing the potential markets for such devices, it is required to check the technology and skills applied in the manufacturing of devices. Analyzing the application and techniques is necessary and scientists here play an essential role. They go through the product data, business plans, etc, to judge the scientific concepts and principles involved in the production of small or large medical devices. 

Regulatory specialists

Regulatory specialists are meant to perform a variety of activities to bring acceptance of important regulatory documents for medical device producing companies. They are actually responsible for insuring timely submission of neat, accurate and complete documents to the clients, regulatory bodies, wherever applicable. Regulatory specialists are known to come with strong verbal, interpersonal and written communication skills to deal different formalities strongly. 

Medical experts

To understand the specification, composition, design, size and other factors of medical devices, medical experts are required. Being an essential part of medical device consultants’ team, medical experts play a significant role in declaring whether the devices are useful for specific medical applications or not before they are presented into the market. 

Quality assurance managers

As far as the role and importance of quality assurance managers are concerned, they are specified to check the quality of devices. Quality assurance managers of medical device consulting firms prepare a summary of device quality reports, submits safety reports, verify the efficiency of devices.  Quality assurance managers check whether the equipments are safe to use by remaining in direct contact with patients, physicians and staff. They check whether such devices are effective to use against hazardous substances, communicable diseases and other emergency situations. 
In this way, medical device consultants’ team plays a vital role in presenting quality medical devices in the market.

Arazy Group has been serving medical device manufacturers with quality medical device registration in around 53 countries of the world. The company is in Vancouver, BC and is specialized in medical device registration.

Exhibitions

As an international company we make sure we are available to our clients around the clock through various channels of communication.  You can reach us by mail, phone, audio or video conference on  or .

Also, we have 24 hours online live chat service, where a professional account manager is available to attend to your needs. It is accessible through all our websites and is available in multiple languages. As an Arazy Group client you can access your own Customer Portal where all your records, current ongoing projects, documents in process could be viewed. Arazy Group’s propriety professional knowledge base of international regulatory affairs, quality assurance and medical product standards are also part of your Customer Portal. We have local offices and agents in various countries around the world. 

Please visit our Contact Us page to find more about the location of those offices and contact details.

As always we would be happy to meet you in any of the exhibitions we attend this year.  Let’s meet!

 

 

Medical Fair Thailand 2011

Bangkok       Thailand

                             

Medical Fair Thailand The will provide vital access for companies trying to penetrate the Southeast Asian markets. The combined population of Southeast Asia which is in excess of  540 million people, changing demographics, longer life expectancy and aging population will have an enormous impact on the need for better healthcare.

Sep 14, 2011 00:00:00 - Sep 16, 2011 00:00:00

 

 

Expo Medical Argentina 2011 

Buenos Aires     Argentina

ExpoMEDICAL International Show for Products, Equipment and  Services for Healthcare sector is the major Healthcare Exhibition in Spanish speaking countries and an essential meeting point for everyone in Medicine in South America.

Sep 28, 2011 01:00:00 - Sep 30, 2011 21:00:00

 

 

RAPS Annual Conference 2011

Indianapolis       USA

 

RAPS is the leading international membership organization for regulatory professionals who are working to ensure the safety, effectiveness and availability of healthcare products, including medical devices, pharmaceuticals and biotechnology. We are dedicated to advancing the profession and providing the highest level of support, knowledge, direction and standards. Convergence of global regulatory profession.

Oct 22, 2011 00:00:00 - Oct 26, 2011 00:00:00

 

 

Medica 2011

Dusseldorf   Germany

The world’s leading organiser of medical trade fairs, the Messe Düsseldorf Group, has staged MEDICA in Düsseldorf for more than 40 years. This leading show in the industry has more than 4,300 exhibitors and 137,000 visitors. International Trade Fair with Congress and World Forum for Medicine 2011. The show will take place November 16 to November 19, 2011 in Düsseldorf.

Nov 16, 2011 00:00:00 - Nov 19, 2011 00:00:00

 

 

RSNA Annual Conference 2011

Chicago        USA

 

The mission of the Radiological Society of North America is to promote and develop the highest standards of radiology and related sciences through education and research. The Society seeks to provide radiologists and allied health scientists with educational programs and materials of the highest quality, and to constantly improve the content and value of these educational activities.

Nov 27, 2011 00:00:00 - Dec 02, 2011 00:00:00

 

 

Medifest India 2011

New Delhi    India

 

Medifest premier medical & healthcare trade event is the grand show that delivers a diverse assemblage of medical suppliers to you at one place at one instance. The show brings high level business opportunities for all related to healthcare industry by providing numerous opportunities of trade expansion.

Dec 15, 2011 00:00:00 - Dec 17, 2011 00:00:00

 

 

Arab Health Conference and Exhibition in Dubai 2012

Dubai   United Arab Emirates

Arab Health 2011 was yet again a resounding success for the global healthcare industry! Arab Health 2012 will reopen January 23-26, 2012 at Dubai World Trade Centre, UAE.  We will be updating our official Facebook page with the latest industry news. Look out for our monthly click Newsletter

Jan 23, 2012 08:00:00 - Jan 26, 2012 06:00:00

 

 

Bio-Partnering North America 2012

Vancouver        Canada

28 February 2011 - Over 800 delegates, from 500 companies and 27 countries joined TVG - Your Global Life Science Network™ and LifeSciences British Columbia at the launch of BioPartnering North America™ 2011 (BPN) today at the Vancouver Convention Centre in Canada. BPN is the premier life science partnering conference in North America.

Feb 26, 2012 00:00:00 - Feb 28, 2012 00:00:00

 

 

China Med 2012

Beijing       China

 

China Med Reputed as the first international exhibition with UFI certification in China, co-organized by the Health Department of General Logistics Department of Chinese People’s Liberation Army, China World Trade Center, Huitong Xingye International Exhibition (Beijing) Co., Ltd. and Messe Düsseldorf China Ltd.



Mar 23, 2012 00:00:00 - Mar 25, 2012 00:00:00

 

 

Hospitalar 2012 TBD

Sao Pãulo    Brazil

2012 TBD | HOSPITALAR – 18th International Fair is a multi sectorial fair that will showcase the novelties of 1,250 exhibiting companies, representing over 30 countries. HOSPITALAR hosts some 89,000 professional visits from all over Brazil and 60 other countries.

May 01, 2012 00:00:00 - May 02, 2012 00:00:00

 

 

Hong Kong International Medical Device and Supply Fair 2012

Hong Kong     China

Asia's premier medical fair, organised by the HKTDC and held at the HKCEC, the Hong Kong International Medical Devices and Supplies Fair offers medical devices and supplies, like medical & laboratory equipment, disposables, and brings together product developers and businesses looking to market these products.

May 02, 2012 00:00:00 - May 09, 2012 00:00:00

 

 

ILSI BioMed 2012 TBD

Tel-Aviv   Israel

It is our honour and pleasure to invite you to ILSI-Biomed. The conference is a meeting place for industry and academia from Israel and abroad. Exuberance is felt everywhere: lectures, exhibition halls and partnership meetings. International visitors come to experience firsthand the entrepreneurial spirit so strongly exhibited within the vibrant Israeli life science community.

May 23, 2012 00:00:00 - May 25, 2012 00:00:00

 

 

Medical Devices Summit 2012 TBD

San Diego, California    USA

Medical Devices Summit | Reducing Risk and Increasing Return through Cutting-Edge Business Strategy and Technological Innovation | Opal Events is proud to bring its blockbuster Medical Devices Summit to the West Coast! Join industry professionals from around the country and around the world !

Jun 01, 2012 00:00:00 - Jun 02, 2012 00:00:00

 

 

Medifest South Africa 2012 TBD

Cape Town      South Africa

2012 TBD | Medifest SA is a premier summit. The main aim of fair is to bring together all those related with medical & healthcare sector under one roof & provide comprehensive information on the current developments in the industry and an ideal sourcing destination.

Jun 07, 2012 00:00:00 - Jun 09, 2012 00:00:00

 

 

 

BIO 2012

Boston MA     USA

The BIO International Convention, the world's largest gathering of the biotechnology industry, innovative healthcare, agricultural, industrial and environmental products along with industry-leading investor and partnering meetings. BIO represents more than 1,200 biotech companies, academic institutions, state biotechnology centers and related organizations across the USA & in 30 nations globally.

Jun 18, 2012 00:00:00 - Jun 21, 2012 00:00:00


RESOURCE :-   www.ArazyGroup.Com

Major Challenges of Medical Device Industry

Every industry has been facing several challenges to deliver best of products and services. Medical device industries have always faced challenges related to technology, reimbursement and market risk, regulatory and the latest financing risk.  

Medical device industry is counted among industries that play effective role in the society. They come up with quality medical devices which are quality tested and authorized by medical researchers and regulatory specialists to ensure the safety and effectiveness of devices. To help such industries for the authorization of small and large devices, professional medical consultants are present.

Let’s check out the challenges which modern medical industries have been facing these days.

Technological risk

The kind of risk which involves the application of right technology for the manufacturing of medical devices is referred as technological risk. Brief survey of the major difficulties and policy issues along with dealing with major technological risks including risk control and risk assessment are all counted among technological risks. The industries come with regulatory and technological experts to face the challenge strongly.

Reimbursement and market risk

The act of compensating the client for an expense is called as reimbursement and one of the major challenges which medical industries have been facing these days. Moreover, the companies need proficiencies to deliver quality products and services to get rid of the reimbursement problem.

As far as market risk is concerned, it deals the way of marketing for the devices. Modern companies follow advanced market research; try to find out the features which are more advanced and useful before the final marketing of devices. In order to get better marketing results, it is essential to manufacture the devices with competitive and safety features along with cost-effective rates. Thus, medical device providers concentrate on all useful factors to get better response.

Financing risk

Medical device companies have faced regulatory, technological, reimbursement and market risks always. It can be said that these risks are not new, a new risk is added to the present set of challenges and that risk is called as financing risk. Some medical products require long development cycle which means large funding requirements. To avoid this risk, the industries take help of several funding options to let the products developed properly.

Regulatory risk

Professional medical device consultants are available to help the companies to avoid problems or risks related to regulation. Customized solutions of consultants accommodate different stages of device’s lifecycle and bring successful registration of medical equipment globally.

Thus, it can be said that medical industries face several challenges and take care of several risks to deliver best quality, effective and safe to use medical equipments.

Choosing a reliable Medical Device Expert

Medical device experts play a significant role in the successful launch of a medical device or equipment on a global level. It is extremely important to choose an expert carefully. Some of the major points that need to be kept in mind have been listed below.

No matter how properly or perfectly a medical device or equipment has been designed, it cannot be accepted by the international market. For a medical device company to launch its medical products on a global level, international acceptance and consultation services are required. Moreover, it also needs various marketing approvals.  

There are different types of medical devices like drug delivery, diagnostic software energy emitting technology, combination devices, active and passive implants, therapeutic devices, ivds, surgical disposables, diabetic products, dental implants, general hospital equipment, dental lab products, imaging and navigation systems, etc. that cannot be accepted by the international market before checking them for various safety and quality standards. Assessments from public health authorities, marketing approvals, regulatory sales clearance, etc. are some of the major requirements for global launch of any product. All these requirements cannot be fulfilled by the medical device manufactures on their own.

 Here the role of medical device experts comes into picture. Such an expert plays an increasingly significant role of supporting innumerable medical device companies in the direction to bring their products into market.   

There are many experts that have been working in the direction to provide customers with quality services in this regard. Before choosing a particular one, one needs to consider some prominent factors in mind. These include:

Experience

Experience is one of the major factors that should always be given priority. You can expect high quality results only by choosing an experienced company. Such a company is well aware of different regulatory strategies that need to be applied on the most advanced and complex devices.

Skilled and knowledgeable team members

This is another major feature that needs to be considered. Choose a company with skilled and experienced consultants capable enough to register thousands of medical devices successfully on a global level. They should carry enough regulatory affairs and quality assurance experience.

Customized solutions

Most of the companies offer customized solutions to the customers. It is good to choose one such company that provides customized solutions accommodating all phases of medical device's life cycle.  

These are some of the prominent factors that should always be given precedence before choosing a quality expert as per your needs, requirements and budget. Internet is the best medium that can provide you with different options in terms of reliable medical device experts. You can go with the one that you find the best.