ISO 13485 Certification in Malaysia

ISO 13485:2016 Certification in Malaysia is found to be most sought after certification requirement to enhance the process and to be a competitive edge in market. Malaysia officially called as Federation of Malaysia is located in Southeast Asia. The infrastructure and the urbanization of the city is well developed with city full of leaning skyscrapers and a Petron as twin towers is one of the major tourist attraction. The economy of Malaysia set to be newly industrialized market economy. Electronic products, Petroleum, products, mining, agriculture, are the major business sectors of Malaysian country. Economy of Malaysia is expected to grow at a faster rate. It is no doubt that pharmaceutical of medical certification in Malaysia is in high demand. Because every industries and business sectors involved in the activities of medical activities are seeking for a long term sustainability in the market

ISO 13485 and it’s importance:

ISO 13485 standard is an International standard developed and published by international organisation for standardization.ISO 13485 consultant in Malaysia can implement ten standard practically. It is one of the Global certification used by professionals and Organisation to get immunity from legal obligation and all other regulatory requirements and statutory requirements.ISO 13485 consultant in Kuala Lumpur is the solution. It is one of the international a good standard for manufacturers, suppliers,vendors and any other organisation involved in the activities of manufacturing or related activities pertaining to medical devices and equipment. ISO 13485 consultant service in Klang is an helping hand. Sometimes the standard holds good for even medical devices and equipment service providers. ISO 13485 Certification in Kuala Lumpur specifies the requirements for Quality Management System specific to medical devices and equipment. Any organisation involved in the life cycle such as designing and development production, supply related service which comes under the purview of ISO 13485 Services in George Town. Medical devices could be anything success instrument approaches machine implant all in with in vitro reagent, or any other similar articles will come under the medical device and instruments section. Not only medical devices but also installation and service related to the medical devices needs to be compliant with ISO 13485 registration in Malaysia to get immunity from legal obligation pertaining to medical device regulators.

Quality management system relating to medical devices – ISO 13485  The business related to medical devices, medical equipment, other related services are critical. So there is a need to establish a sound quality management system in the manufacturing of medical devices and also quality should be inculcated in the service provided to the customers. It is highly recommendable to go for ISO 13485 Certification in George Town. And quality is only possible when there is a sound quality management system in place. Test quality management system is a basic requirement for ISO 13485 implementation in Malaysia. By adopting quality management system an organisation can witness continual improvement and customer satisfaction if and only if the standard is implemented practically with the help of Plan-Do-check-Act cycle also called as PDCA cycle. ISO 13485 audit service in Malaysia will ensure your organization conducting the cycle on a regular basis. PDCA cycle is basically a simple powerful tool to ensure continual improvement in the organization.

How Certvalue can help you?

Certvalue is a one stop solution providing consultation, audit and certification. It is a leading global company providing 100% satisfaction to its customers. ISO 13485 certification cost in Kuala Lumpur is economical and affordable with Certvalue. Consultants of the company are well aware of the standard and trying to inculcate industrial best practices to their customers walking through positive growth of the organization. Consultant will implement the standard practically to gain all the benefits available from the standard. We value our customers time and money. Cost of ISO 13485 in Malaysia is worth investing with Certvalue. So, any project with Certvalue will include time and money in the scope of the project.

How to get ISO 13485 Certification in Malaysia?

If you are wondering how to get ISO 13485 certification in Malaysia. There is always Certvalue to be an helping hand to the customers by providing them end to end solution. ISO 13485 registration in Malaysia is a cake walk process by approaching Certvalue. You can easily reach Certvalue by simply visiting www.certvalue.com where you can chat with an expert or you can also write an enquiry to [email protected] so that one of our expert shall contact you at the earliest to provide best possible solution available in the market.

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Sobiya Rajesh
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We are happy on Certvalue services. The team guided through applicable SOPs, forms and policies to implement QMS and manage it effectively so as to comply with ISO requirements. It included training part as well. Hence we are satisfied and recommend anyone who seek professional service.
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Certvalue team was very professional in their approach from the time we engaged them. Special mention to Ms. Jeevika Uchil who consulted and worked extensively with our team.
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CyberDome Nigeria Limited. CertValue made the acquisition of our ISO 27100 certification seamless. The person assigned to us Jeevika Uchil was very helpful.
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Shehan Athukorala
Shehan Athukorala
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Certvalue is a very professional and responsive consultation firm. It did show us the right direction towards the ISO and GMP certifications for the PPE devices we are manufacturing. Hoping to work with them for ISO 13485 /CE and FDA as well. Well recommended for all.
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We got good service from certvalue and its team I was satisfied,thank you Certvalue for making my work easy
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Thank you certvalue, we have built information security management system in our organization with the help of certvalue. They were really help to get certified under iso 27001. Thank you.
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Certvalue team was very responsive right from the time we contacted them for the first time. Consultants who worked with us were very professional and demonstrated a lot of patience to get us through required documentation / requirments for the certification. Thank you Certvalue!
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