ISO 13485 Certification in Singapore

ISO 13485 Certification in Singapore is a pivotal recognition for businesses operating in the medical device industry.A commitment to upholding the highest standards of quality and legal compliance is evident by the accomplishment of this certification. Businesses who want to provide dependable medical goods that boost customer confidence and market access must achieve ISO 13485 Certification in Singapore.

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ISO 13485 Consultant in Singapore is a professional consultant for providing ISO 13485 Certification in Singapore, Hougang, Tampines, Pasir Ris, Yishun, Choa Chu Kang, Toa Payoh, Bukit Batok, Queenstown, Clementi, Serangoon, Sembawang and other major cities in Singapore with the services of implementation, Documentation, Audit, Templates, training, gap analysis, registration process at affordable cost to all organization to get certified under pharmaceutical of medical manufacturing in Singapore.ISO 13485:2016 certification in Singapore is a sector specific variation on ISO 9000 basic structure and you update towards to make sure that it gives satisfactory management system for medical devices. It’s not been around all that long one can imagine that with medical devices you do really  have to be very careful and you should have a management system that is going to guarantee the quality of that devices that is being send to the Marketplace. This is becoming more and more popular now which includes medical devices them self include and components that go to the medical devices. ISO 13485 Certification Services in Singapore standard requires a documentation procedure to define the requirements for reviewing nonconformity including customer complaints coma meaning the causes of non conformity which is also often called as root cause analysis, evaluating the need for action to avoid recurrence to ensure that nonconformity do not reoccur, defining how action is needed to determine and implemented including is appropriate updating the documentation, recording the results of Investigation or action taken defining the documents to reviewing the corrective action taken and its effectiveness.

ISO 13485 registration services in Singapore you have to identify the processes that is applicable to the quality management system and insured how they are interconnected and controlled using risk based approach. You have to document your QMS to references you do it in a quality manual. e devices type or family must be documented in a medical device file. You have to keep the records where appropriate and all the relevant documentation and the record must be controlled as a documented procedure. ISO 13485 registration in Singapore specifies the top management to show its commitment to establishing and maintaining an effective quality management system. This means to establish the quality policy and setting the quality objectives for the whole organisation. The top management has to define and document the responsibilities and authorities for effectively operating of the organisation in conformity with it’s QMS. ISO 13485 audit services in Singapore including to the point of Management representative who will be responsible for to prepare the report on effectiveness of the QMS at management reviews conducted at planned intervals. The standard specifies to provide the required resources necessary for the effective QMS. You have to identify the people and the job setting the product quality and ensure that these people are competent. You are supposed to provide the infrastructure and work environment needed to ensure medical medical device safety and performance. Such as health, cleanliness and and clothing requirements where this could affect the product quality where applicable you should make sure that you prevent contamination if you have the product meeting this kind of control.

The consultant of ISO 13485 certification in Singapore should make sure the requirement for operations starting with planning and develop the processes needed for product realization for ISO 13485  implementation in Singapore . You have supposed to set the quality objectives mutual meet the customers and regulatory requirements and make sure that there is a necessary arrangements for communication with customers and medical device regulator’s. The Consultants of ISO 13485 Certification in Singapore should also make sure that design and development procedures and organised design and development activities effective design verification and validation is very important requirement and at this stage prior to design transfer to manufacturer when you have to document the requirement for purchasing such such as to control the selection of suppliers and to monitor the supplier performance also to inspect and verify the vendor processes. ISO 13485 specifies that you should plan and implement the production and service provision where it has to be monitored. You are supposed to be fine you can close for contamination be controlled which is applicable. And you are also supposed to document the product installation and verification requirements. You are also supposed to document the service in procedure, sterile medical devices and product process validation.

What are the advantages from ISO 13485 Certification in Singapore?

  • ISO 13485 Consulting Services in Singapore will help to increase the company brand value in the international market resulting in the benefit of Business expansion in international countries leading to increased profit.
  • ISO 13485 certification in Hougang  will help you to increase the customer confidence the product being manufactured resulting in increased sales.
  • ISO 13485 Consultants in Pasir Ris will help to get more business from the government tenders as it would be one of the mandatory requirement in order to participate in the bidding.
  • ISO 13485 consultancy services in Singapore will help to identify all the risk involved in the process.

How to get certified for ISO 13485 certification in Singapore?

We are one of the one stop solution provider for all of your certification requirement. We are one of the Global leaders for consultation and certification for international standards and other technical standards for both process and products. Yeah one of the Consulting company who believe in continual improvement and customer satisfaction which is one of the key for the success in business. We are one of the result oriented the company who helps our customers to implement a management system in place and help to achieve the intended results from it. With us The cost of ISO 13485 Certification in Tampines is always minimal for all of our customers.

How to get ISO 13485 Consultant in Singapore?

If you are looking how to get ISO 13485 certification in Singapore you can write to us at [email protected] or visit our official website at to know more about us and our company. Our help desk personal will be always available 24/7 to assist you on the certification requirements what you have to do is to just register yourself with your contact information so that one of our Consulting experts shall contact you at the earliest to get your business certified.

Checklist for ISO 13485 Certification in Singapore


The ISO 13485 Certification Audit Checklist covers the seven main areas of the ISO Standard:

  • ·  Context of the organization
  • ·  Leadership
  • ·  Planning
  • ·  Support
  • ·  Operation
  • ·  Performance evaluation
  • ·  Improvement


Certvalue is a reputable and widely recognized global leader in the provision of certification, advice, audit services, and ISO 13485 Consulting Services in Singapore anywhere in the world. It operates ethically and has an unmarked track record of achievement in the certification process. Certvalue’s  ISO 13485 consultants in Singapore have a wide range of knowledge and expertise in many fields and industrial sectors. Organizations pick Certvalue to handle complex solutions because of the service’s superiority. With Certvalue, registering for ISO 13485 Certification in Singapore is simple and fast.

Cost Of ISO 13485 Certification in Singapore

The cost of obtaining ISO 13485 Certification in Singapore can vary widely based on several factors. The easiest way to get the cost is using our Free cost calculator and get the cost for your ISO 13485 Certification instantly in your email.

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Asked Any Questions

ISO 13485 Certification is an internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. It is essential for manufacturers as it ensures compliance with rigorous quality standards, adherence to regulatory requirements, and a commitment to patient safety.

Yes, ISO 13485 Certification is adaptable and can be tailored to specialized medical device sectors, allowing organizations to meet specific regulatory and quality requirements.

ISO 13485 Certification incorporates risk management principles, helping manufacturers identify, assess, and mitigate risks associated with medical devices, enhancing product safety.

Absolutely, ISO 13485 Certification encourages organizations to establish efficient and controlled processes, reducing errors and improving the overall quality and reliability of medical devices.


Conduct Gap Analysis to find any Shortcomings from the standard requirements.


Policies, procedures, Work Instructions, Evidences, Records, Training


Conduct frequent internal audit and management review meeting.


Apply corrective actions on the identified root cause or shortcomings


Process for ISO Certification in Singapore

Certvalue make the ISO certification process in a simple way for every organization in singapore to get their certification sitting at their place in lesser time and at an affordable cost.

Get Consultation

Seek guidance from Certvalue to determine the relevant ISO standards.

Submit Your Documents

Collect and prepare the required documents and records.

Get Audited

Undergo a thorough audit by Certvalue’s auditors to assess compliance.

Get ISO Certificate

Upon successful audit, receive your ISO certification from Certvalue.





Bottom-line of any business organization is profit and Customers are the only source of Profit. Certvalue will help balancing both customer and compliance requirement at the same time with the help of ISO certification


Enhancement of Performance

ISO certification is a tool to streamline and enhance the process performed internal to the organization. Certvalue indulges in inculcating best industry practices.


Recognition and Brand Value

It is always about the Brand value of your organization in the market and ISO certification from Certvalue can make your organization to be an excel and stand out in the market globally


Tender Eligibility

ISO certification is a basic requirement to bid or participate in any tenders floated by government or private sector. And ISO certification from Certvalue is an assurance win over the tenders.

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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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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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