Q: What should include the quality management system documentation for medical device manufacturers according to ISO 13485?

CE Marking - For medical products intended for the European market, CE marking is important. The documentation should include the procedures related to the CE marking process, including compliance with medical directives and harmonized standards. Technical Documentation - The technical documentation of the product should contain all necessary information confirming the compliance of the medical device with the requirements of ISO 13485 and other relevant industry standards. Quality Control Procedures - The management system should include detailed quality control procedures that are applied during production as well as in the product conformity assessment process. Change Management - The process of managing changes in documentation and in the product itself must be clearly defined. These changes may result from improving the product, adapting to new standards or reacting to possible quality incidents. Corrective and Preventive Actions - The documentation should include information on corrective and preventive actions that were taken in the event of non-compliance of the medical device with the requirements.

Q: What legal provisions regulate medical devices?

The Medical Devices Act - of 20 May 2010 on medical devices (Journal of Laws of 2017, item 2193, as amended) is the legal basis for introducing medical devices to the market in Poland. This act is harmonized with European medical directives. Regulation of the Minister of Health - of 11 July 2014 on the types of medical devices, the scope of information contained in the declaration of conformity and the method of its delivery (Journal of Laws of 2014, item 929) specifies detailed requirements for the types of medical devices and procedures related to the declaration of conformity. Regulation of the European Parliament and of the Council on Medical Devices CE Certification - Medical devices placed on the market in the European Union must have the CE mark, which means that they meet the relevant requirements of European directives. The CE certification process includes a conformity assessment and is a key element of the legal introduction of a medical device to the market.

Question 1

What is ISO 13485?

Accepted Answer

ISO 13485 is an international standard developed by the International Organization for Standardization (ISO) that concerns quality management systems in the medical industry. This standard is dedicated to manufacturers of medical devices and includes requirements for the design, production, installation and operation of these devices. The purpose of ISO 13485 is to ensure compliance with regulations and standards regarding the safety and effectiveness of medical products. Organizations that obtain a certificate of compliance with ISO 13485 confirm that their management systems are in line with the highest quality standards in the medical industry. This standard also supports the processes of tracking and identifying medical products, which is crucial in the case of responding to emergency situations or product recalls.

Question 2

What is a medical device?

Accepted Answer

A medical device is a product designed specifically for medical use, the purpose of which is to treat, diagnose, monitor, or support the vital functions of the human body. Medical devices include both medical devices, such as scanners, and disposable products, such as dressings or syringes. A medical device can be used by both medical professionals and patients in hospital, outpatient, or home settings. In order to introduce a medical device to the market, it is necessary to meet rigorous quality standards and regulations governing its safety and effectiveness.

Question 3

How to obtain the qualifications of an internal auditor or representative of the quality management system of medical device manufacturers ISO 13485

Accepted Answer

The qualifications of an internal auditor or a representative of the quality management system for manufacturers of medical devices compliant with ISO 13485 require only auditor knowledge and knowledge of ISO 13485 and ISO 19011 standards. Usually, however, auditors during ISO 13485 certification ask for such confirmation. To obtain such confirmation, it is enough to take part in a training (online or stationary), or if you know the required standards, you can take an exam.

Question 4

What is the compliance process?

Accepted Answer

In the context of ISO 13485, conformity assessment of a medical device covers the processes related to confirming whether the product meets the requirements defined in the technical specifications, industry standards, as well as legally defined requirements.

Question 5

What should include the quality management system documentation for medical device manufacturers according to ISO 13485?

Accepted Answer

CE Marking - For medical products intended for the European market, CE marking is important. The documentation should include the procedures related to the CE marking process, including compliance with medical directives and harmonized standards.
Technical Documentation - The technical documentation of the product should contain all necessary information confirming the compliance of the medical device with the requirements of ISO 13485 and other relevant industry standards.
Quality Control Procedures - The management system should include detailed quality control procedures that are applied during production as well as in the product conformity assessment process.
Change Management - The process of managing changes in documentation and in the product itself must be clearly defined. These changes may result from improving the product, adapting to new standards or reacting to possible quality incidents.
Corrective and Preventive Actions - The documentation should include information on corrective and preventive actions that were taken in the event of non-compliance of the medical device with the requirements.

Question 6

What are the benefits of having ISO 13485 certification?

Accepted Answer

The ISO 13485 certificate proves that the legal and medical requirements of the product have been met and that the organization has a specific quality management system that complies with international standards for manufacturers of medical devices. This confirmation guarantees that the company uses procedures and practices that ensure the safety, effectiveness and compliance of medical products with regulatory requirements. The ISO 13485 certificate is recognized as proof of commitment to maintaining the highest quality standards in the medical industry.

Question 7

What legal provisions regulate medical devices?

Accepted Answer

The Medical Devices Act - of 20 May 2010 on medical devices (Journal of Laws of 2017, item 2193, as amended) is the legal basis for introducing medical devices to the market in Poland. This act is harmonized with European medical directives.
Regulation of the Minister of Health - of 11 July 2014 on the types of medical devices, the scope of information contained in the declaration of conformity and the method of its delivery (Journal of Laws of 2014, item 929) specifies detailed requirements for the types of medical devices and procedures related to the declaration of conformity.
Regulation of the European Parliament and of the Council on Medical Devices
CE Certification - Medical devices placed on the market in the European Union must have the CE mark, which means that they meet the relevant requirements of European directives. The CE certification process includes a conformity assessment and is a key element of the legal introduction of a medical device to the market.

Question 8

What can be a medical device?

Accepted Answer

Medical devices include a variety of products designed to diagnose, treat, monitor, or support the vital functions of patients. Here are some examples of the different categories of medical devices:
Diagnostic Equipment: Electrocardiographs (EKG), Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Glucometers (for measuring blood glucose levels)
Surgical Instruments: Surgical Scalpels, Surgical Forceps, Electrocautery (for tissue coagulation)
Monitoring Equipment: Vital signs monitors (e.g. blood pressure, pulse, oxygen saturation monitoring), Electrocardiographic monitoring devices (Holters)
Laboratory Equipment: Microscopes, Spectrophotometers (for chemical analysis), Centrifuges (for separating substances)
Implants and Prostheses: Artificial heart valves, Joint prostheses (e.g. knee and hip prostheses), Electronic hearing implants
Dressings and Dressing Materials: Wound dressings, Adhesive plasters, Surgical suture materials
Disposable Products: Disposable syringes and needles, Disposable gloves, Blood collection tubes
Physiotherapy Equipment: Muscle Electrostimulators, Therapeutic Ultrasound Machines, Electrotherapy Equipment
Dental Equipment: Dental Drills, Dental Radiographs, Dental Unit

Question 9

What are the classes of medical devices?

Accepted Answer

In the European Union and other jurisdictions, the classification of medical devices is based on the risk associated with their use, and these criteria are defined in the relevant regulations. In the European Union, categories A, B, C, and D are used, each representing different levels of risk. This classification applies to the CE certification process, which is necessary to place a medical device on the European Union market. Here is a general explanation of the classes of medical devices:
Class I:
It includes medical devices that pose a low risk to the patient and are usually products that are simpler in terms of design and function. Class I includes, for example, dressings, non-electric thermometers or massage balls.
Class IIa:
Moderate risk medical devices that require greater control compared to Class I. These include knee prostheses, injection equipment, and electric thermometers.
Class IIb:
It includes medical devices with higher risk, requiring more detailed clinical testing and production control. This class includes, for example, vascular stents, endoscopes or dental implants.
Class III:
The highest risk concerns Class III medical devices, which often require full clinical trials. Examples include artificial heart valves, brain implants, and advanced vital signs monitoring systems.
It is worth noting that this classification refers to the risk associated with the medical device, not its technical complexity. Regulations and classifications may vary by region and regulatory system, so it is always important to comply with applicable local and international regulations.

ISO 13485 Implementation and certificate of the quality management system
for manufacturers of medical devices

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ISO 13485 and ISO 9001 standard

ISO 13485 Certificate

How much does ISO 13485 implementation and certification cost?

Free cost estimation for ISO 13485 certificate

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Questions about medical products and ISO 13485

What is ISO 13485?

What is a medical device?

How to obtain the qualifications of an internal auditor or representative of the quality management system of medical device manufacturers ISO 13485

What is the compliance process?

What should include the quality management system documentation for medical device manufacturers according to ISO 13485?

What are the benefits of having ISO 13485 certification?

What legal provisions regulate medical devices?

What can be a medical device?

What are the classes of medical devices?

Also check out our knowledge base

Medical devices – new EU regulations

How to manage risk?

ISO 13485 Implementation and certificate of the quality management systemfor manufacturers of medical devices

How to get ISO 13485 certificate

ISO 13485 and ISO 9001 standard

ISO 13485 Certificate

How much does ISO 13485 implementation and certification cost?

Free cost estimation for ISO 13485 certificate

See other ISO 13485 services and products

Questions about medical products and ISO 13485

What is ISO 13485?

What is a medical device?

How to obtain the qualifications of an internal auditor or representative of the quality management system of medical device manufacturers ISO 13485

What is the compliance process?

What should include the quality management system documentation for medical device manufacturers according to ISO 13485?

What are the benefits of having ISO 13485 certification?

What legal provisions regulate medical devices?

What can be a medical device?

What are the classes of medical devices?

Also check out our knowledge base

Medical devices – new EU regulations

How to manage risk?

ISO 13485 Implementation and certificate of the quality management system
for manufacturers of medical devices