ISO/IEC 13485 | Medical Devices

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Medical Devices QMS

Get a certificate in Medical Devices Quality Management System and have your products and services certified by a leading certification company.

With the ISO 13485 certificate (Medical Devices Quality Management System - MDQMS), you send your customers, business partners or authorities a clear message that the quality of production and distribution of medical devices is at a high level in your company. At the same time, you show that you meet all the requirements of strict health legislation.

At TAYLLORCOX, we have over 10 years of experience with MDQMS. Our high expertise is also evidenced by the fact that our specialists have extensive experience in healthcare. Our auditors have professional experience as medical practitioners, senior doctors or managers of medical facilities. We are also part of the Czech Society for Accreditation in Healthcare and audit inpatient care to legislative standards approved by the Ministry of Health.

Due to its specificity, only a limited number of companies offers ISO 13485 certification. However, only TAYLLORCOX offers a unique mix of benefits:

Speed

We can implement the certification process up to 75% faster than our competition.

Customization

We will design a specific certification procedure to suit your current situation.

Success

Our know-how and client orientation result in a highly successful certification process.

Training

As the only certification body on the market we will also provide training for you and your employees.

More about TAYLLORCOX certification benefits

Why get certified to the ISO 13485 standard?

The introduction of a quality standard in the production and distribution of medical devices is a necessity for many companies. However, the certification brings many other benefits than just meeting the legal obligation or conditions for entering the field of healthcare:

You will strengthen the image and credibility of your company in the eyes of customers, business partners as well as employees. It will be clear that the quality of products and services is a key value of your company.
You will meet the necessary qualification conditions for entering healthcare, which involves strict control of medical legislation.
With the ISO 13485 certification you get the opportunity to apply for public contracts in the field.
You will gain new customers as ISO 13485 demonstrably increases interest in quality products.
You will implement a systemic and systematic approach to product security, proactively prevent errors and identify them in time if they do occur.
You will meet the expectations of your customers thanks to reliable deliveries of quality as well as safe and effective medical devices.
You eliminate process deficiencies and increase your efficiency. This will lower your costs and increase profitability.
You will get a tool for more efficient supply chain management.

ISO 13485 certification process in 3 steps

At TAYLLORCOX we have developed a unique three-phase certification process that allows us to proceed with unrivalled speed and efficiency.

We will pass the necessary knowledge to your employees.

One of the conditions for obtaining ISO 13485 is demonstrable relevant knowledge of your employees. All necessary training is conducted by internationally accredited auditors with extensive experience in healthcare. They will introduce you to quality standards in the production and distribution of medical devices and train selected employees for the position of internal auditor.

We have prepared a supporting materials package for you. This will facilitate your path to successful certification.

The sophisticated document system for the ISO 13485 standard includes a full set of templates, samples and forms to guide you through the compilation of a key manual, including checklists. With these, you will ensure that you have optimized all processes in the company as required by legislation and the certification. The authors of the toolkit are our accredited auditors, leading experts in ISO 13485, who guarantee the factual accuracy and quality of all materials.

Get confirmation that your business processes meet strict quality standards in the field of production and distribution of medical devices.

The certification will be performed by our lead auditor. The first stage of the internal audit - desktop review - will focus on the description of the current state of security documentation in terms of its complexity and completeness. It will be followed by a process review, where we will evaluate the compliance of the documentation with reality and compile a list of necessary measures.

Successful certification is followed by regular annual audits, and a recertification every three years.

Why choose TAYLLORCOX for your ISO 13485 certification?

We will analyse your situation and we will design a specific certification procedure to ensure it meets your real needs. Moreover, we can flexibly respond to your ad-hoc requests during the certification process.
We are part of an international company which is the basis of our know-how and background. Our auditors are top experts taking part in the creation of relevant laws.
We will take over most of the administrative burden for you and thanks to our experience and detailed customization we can implement the certification process up to 75% faster than our competition.
As the only accreditation body on the market, we will also provide training for you and your employees. This is one of the reasons why the vast majority of our certifications result in success.
We offer the best quality : certification price ratio. We manage to adapt to corporations as well as start-ups, and our outputs are always just as precise. Although our team is full of renowned specialists from a wide range of industries we are completely normal people. We provide clients with the best customer care and devote our energy to their education.
We are the only company on the market to provide comprehensive certifications for healthcare, including inpatient patient care or cyber protection of patient data. Our big advantage is absolute knowledge of the environment as Tayllorcox experts have professional experience as medical practitioners, senior doctors or medical facility managers.
Through a worldwide network of leading experts we are ready to carry out an audit, regardless of whether your medical facility is in Germany, Switzerland, Austria or the Czech Republic.
We are part of the Czech Society for Accreditation in Healthcare. As a member, we are authorized to evaluate the quality and safety of health services in accordance with Act No. 372/2011 Coll. and Decree No. 102/2012.
We constantly bring news and important information (not only) about MDQMS on our blog.

About ISO 13485

The ISO 13485 certificate confirms that the organization complies with the standardized MDQMS standards. When you certify your company to the ISO 13485 standard, you send your customers, business partners or authorities a clear message that MDQMS is at high level in your organisation and security is your priority.

ISO 13485, referred to as the quality standard in the production and distribution of medical devices, is a fundamental standard for entering the market of medical devices, technologies, documentation and additional services. MDQMS certification is essential for meeting the industry-wide regulatory requirements and health standards.

This International Standard for Medical Devices is based on the ISO 9001 standard. Its original focus was medical device manufacturers however in the latest updated version it also includes all suppliers and customers in healthcare. It has become a global standard and a ticket to the world of medical devices in Europe, Australia, Japan, the USA and Canada.

We are the only company on the market to cover comprehensive certifications for healthcare, including inpatient patient care or cyber protection of patient data. The range of our services includes everything that medical facilities need: professional training for staff, GAP analysis, optimization of the management system of medical processes and procedures, internal and certification audits according to the regulations of the Ministry of Health and ISO standards. Our professional auditors have extensive experience in the field. They have professional experience as medical practitioners, senior doctors or managers of medical facilities. Thanks to our absolute knowledge of the environment and a worldwide network of leading experts, we are ready to carry out an audit beyond the borders of the Czech Republic.

We are part of the Czech Society for Accreditation in Healthcare which entitles us to evaluating the quality and safety of health services in accordance with Act No. 372/2011 Coll. and Decree No. 102/2012 and audit inpatient care to legislative standards approved by the Ministry of Health of the Czech Republic.

Legislative framework

In EU countries, the requirements of the ISO 13485 standard are part of Council Directive 93/42 / EEC (93/42 / EEC) as well as national legislation (in the Czech Republic, Government Regulation No. 336/2004 Coll.). The standard also extends to other EU directives, such as In Vitro Diagnostic Medical Devices 98/79 / EC (in the Czech Republic as Government Regulation No. 453/2004 Coll.) or Active Implantable Medical Devices 90/385 / EEC, (in the Czech Republic, Government Regulation No. 154/2004 Coll.). With the ISO 13485 certification you will therefore meet the key requirements of these standards in all EU countries.

FAQ

What is ISO 13485 for?

Although the ISO 13485 standard evolved from ISO 9001, it differs from the original standard in many respects. While ISO 9001 focuses on customer satisfaction and continuous improvement, ISO 13485 focuses on compliance with legislation. Another key element is risk management in the area of design and development, and validation of the process of manufacturing a medical product or providing a service.

How can ISO 13485 help us?

This standard is absolutely essential for organizations working in the field of healthcare. Only via the ISO 13485 certification you can prove that you meet the medical standard. A valid ISO 13489 certificate also allows you to tender for public contracts. There are also countless secondary benefits: with MDQMS you gain a better market position, strengthen your brands, show the quality of your risk management system, set up effective workflows, and more.

Can the ISO 13485 standard be used in areas other than healthcare?

The standard focuses primarily on medical devices. The certification is suitable for any company that focuses on the production of medical products, operation of equipment, provision of medical services or IT solutions for healthcare in general. ISO 13485 certification often runs in parallel with ISO 9001 (Quality Management System), ISO 14001 (Environmental Aspects Management) or ISO 27001 (Cyber Data Protection).