ISO 13485 Certification in Singapore

As you aim to achieve international recognition and access to the global medical device market, consumer trust is won through the assurance of having a proper ISO 13485-certified Quality Management System (QMS) in place.

Our Professional Services

ISO 13485:2016 Medical Devices Quality Management Systems

Our experienced team of in-house ISO consultants can plan and guide you through this process smoothly, covering critical areas for your company, as follows, to ensure you are well-established.

Benefits of getting ISO 13485 certification

The most tangible benefit of having certification to the global standard – ISO 13485 Medical Device Quality Management Systems – is market access. In most countries, the lack of this certification means that the company cannot operate in the medical devices industry. The products cannot be marketed for the same reason. That usually forms the most significant barrier to market entry.

If that is not already the most apparent benefit, companies with the ISO 13485 certification can also:

• Meet customer requirements and increase customer satisfaction through quality systems, meet product requirements and brand reputation;
• Meet the requirements of applicable statutory and regulatory requirements;
• Address product requirements, product quality and product safety without losing focus on business operations;
• Improve clarity on management responsibility, decision-making processes;
• Provide guidance towards proper resource management, including the people, infrastructure, processes involved, and overall work environment; and
• Show commitment and focus towards patient safety.

ISO 13485 certification cost in Singapore

ISO 13485 certification cost varies depending on your scope of works and your desired certification body to work with. Get in touch with us, and we can assist in getting a quotation from them!

Stendard's ISO 13485 consultants in Singapore

1. Identify the appropriate standard(s) that applies to your company, like the ISO 13485:2016 Quality Management System;
2. Identify the scope of your ISO 13485 certification, set up appropriate processes and documentation;
3. Share knowledge on the ISO 13485 certification process;
4. Ensure medical devices’ design and development work is thorough;
5. Ensure comprehensive coverage of medical devices’ production and manufacturing activities;
6. Ensure that distribution channels for the medical devices, while extensive, are well-managed;
7. Ensure the competency of your team regarding ISO 13485 standards and requirements through the conduct of training courses;
8. Perform annual internal audit services with your team to ensure the effectiveness of your Quality Management System in preparation of ISO 13485 certification;
9. Recommend your team to third-party certification bodies providing ISO 13485 certification audit services.

Our consultants advise on which standard applies to your organisation

ISO 13485:2016 Medical Devices Quality Management Systems

Of the many ISO standards to abide by, our consulting team would be able to best advise which applies to your company, to ensure appropriate compliance where necessary. You may find more than one ISO standard applicable to your medical devices and related services, and we can help you effectively integrate them to avoid unnecessary overlaps. For example, for Software as a Medical Device (SaMD) companies sometimes decide to adhere to both ISO 13485 (Medical Devices Quality Management System) and ISO 27001 (Information Security Management System).

QMS Compliance

Our consultants scope your ISO 13485:2016 certification, setting up appropriate processes and documents for your Quality Management Systems.

Keeping in mind your current business practices, we work closely with your team to develop a robust Quality Management System (QMS) with minimal disruption to ongoing business activities, keeping in mind your customer requirements. Building on existing processes, we ensure compliance with your ISO 13485 certification requirements through the introduction of additional processes as needed.

Our structured approach to your QMS implementation provides a clear timeline for project milestones to be reached. Enjoy time saved through efficiency as we work closely over our Stendard Solution™ platform, which allows for the smooth assignment of tasks and online collaboration, putting your management at ease by providing a birds’-eye view at all times.

Through years of experience with ISO 13485 certification audits of a variety of medical devices companies owning hardware & software products and services, our consultants will have you prepared for official audits conducted by your appointed ISO 13485 certification bodies.

Product Development (Design & Development)

Our consultants review and confirm that your medical devices’ design & development work is completely in accordance to ISO 13485 requirements.

We keep your medical devices’ product registration and business strategies in mind as we put together your Design History Files (part of ISO 13485 requirements) so that your records are comprehensive enough to meet regulatory and customer requirements. This includes technical information as we help identify and highlight the depth of tests required (for example with clinical evaluation, sterility tests, software validation, etc.) for your medical devices.

With that, you can be ready for easy expansion to international markets! Our clients have entered major markets around the world: Singapore HSA, EU (under the new MDR), US FDA, Australia TGA, Canada MDEL, to name a few.

Production, Manufacturing & Distribution

Our consultants ensures that you have comprehensive coverage for your medical devices from production & manufacturing to distribution activities, with compliance to ISO 13485.

As we are increasingly well-connected globally, part of your organisation’s medical devices may have been outsourced to various vendors or contract partners, while the core business activities were kept in-house.

These activities may span the spectrum of the entire industry, from manufacturing and assembly to the distribution and installation of medical devices.

Regardless, all processes need to be set up well, and our consultants can provide recommendations on how this may be done, in accordance with ISO 13485. From the evaluation of cleanrooms and factory layouts to quality checks to be performed, software validation to IQ, OQ, PQ tests to be run, you can be assured that our broad experience provides thorough support for the set-up of production and manufacturing processes. We also advise on best practice distribution management to ensure traceability, in order to perform post-market surveillance activities when needed, such as that of customer requirements, feedback, product recalls, and post-market clinical follow-up.

Post-setup of your Quality Management System, internal, supplier, and distributor audits would need to be performed on a regular basis (usually annually) to ensure compliance to regulations and standards. As required, we will walk the ground with you during these audits to ensure that all activities are compliant with your ISO 13485 certification and any other medical devices’ regulations.

Training and Competency

Our team ensures the competency of your team regarding ISO 13485 standards and requirements.

We will include a combination of online training courses and in-person training to make sure everyone within your team understands the requirements of the medical devices’ regulations and ISO 13485 standards and the application of your Quality Management System (QMS) processes and documents.

Some of the e-learning course that we have created includes:

• ISO 13485 Medical Devices QMS (Awareness course) — Topics covered here include a clause-by-clause explanation for your team members to gain familiarity with the requirements; and
• Internal auditing for ISO 13485 Medical Devices QMS — Topics include a full audit checklist where we share the methods to spot evidence and gap holes, according to the proprietary ISO 13485 requirements checklist.

After that, we will conduct a face-to-face or online discussion session customised to your organisation’s needs for clarifications to be addressed, and an opportunity to brief the management on the readiness towards an audit conducted right after.

Frequently Asked Questions

How do I get ISO 13485 certified?

Stendard can help your organisation by providing ISO 13485 Medical Device Quality Management Systems consulting services with experienced ISO 13485 consultants. We help individual clients prepare, establish, implement and improve their medical device management system processes, including gap analysis, auditing, training and arranging for certification services from an internationally recognised certification body.

Is ISO 13485 mandatory for medical devices?

ISO 13485 Medical Device Quality Management Systems is not mandatory for medical devices. For regulatory purposes, it is highly recommended for all organisations involved in medical device manufacturing, design and development, and distribution activities.

ISO 13485 also depends highly on your medical devices’ risk classification, according to various country’s regulatory requirements. For example in the United States of America, the Food and Drug Administration (FDA) specifies the need for compliance to the 21 CFR Part 820 Quality Systems instead of ISO 13485. It is highly recommended to have an ISO 13485 Quality Management System in place as it fulfils most of FDA’s 21 CFR Part 820 Quality Systems requirements.

What is the difference between ISO 13485:2016 and EN ISO 13485:2016?

EN ISO 13485:2016 Specifies additional requirements in the Annexes to the European Union’s regulations, while ISO 13485:2016 does not. The main content clauses, however, do not differ.

Companies seeking to market their medical devices in Europe are recommended to comply with the new EN ISO 13485:2016+A11:2021 standard.

What is the current version of the ISO 13485 standard?

The current version of the ISO 13485 Medical Devices Quality Management Systems is ISO 13485:2016.

Does ISO 13485 replace ISO 9001?

Partially. To add to the challenge, the most commonly adopted ISO standard — the ISO 9001 standard is also known as a Quality Management System. However, the ISO 9001 standard applies to many other industries, including construction, engineering, manufacturing, hotels & hospitality, to name a few.

Being the number 1 most popular standard being certified to, anyone in this industry would be familiar with the ISO 9001 standard or have worked with an organisation with the ISO 9001 certification. This dramatically impacts the impression that the ISO 13485 standard is very similar, which is far from the truth due to the standard’s differences in structure and framework.