Definition of a Medical Device
A medical device is any instrument, apparatus, material or any other related article, used independently or with software that controls and ensures its proper functioning, as determined by the manufacturer, and that is designed for people’s medical purposes, to:
- diagnose, prevent, monitor, treat and mitigate the symptoms of diseases
- diagnose, monitor, treat, mitigate injuries or disabilities
- test replace or change anatomical structure or physiological processes
- conception and birth control
Medical devices are referred to as means that support the above for which pharmacological, immunological or metabolic means fail to achieve the principal aims.
Medical Device 93 /42 /EEC.
The Company’s Achievements
Master Pharm have been specialising in medical products since 2010 in compliance with Quality Assurance Policy. Master Pharm SA as a manufacturer of medical devices, define their policy and guarantee of further development by prioritizing customer’s satisfaction achieved by high quality and safety of the medical products. The year 2010 also saw a successful assessment resulting in the award of the Quality Management System Certificate in Medical Device Manufacturing and Supplying, which evidences the performance to the highest quality standards.
The company is a holder of Quality Management System No 17/3/2013, issued by PCBC (the Polish Centre for Testing and Certification) the EU Notified Body No 1434 and IQNet Association. The company’s performance within medical device is regulated in compliance with the regulations under Medical Devices Directive 93/42/EEC. Our company also follows the standards of PN-EN ISO 13485: 2012 comprising of ‘Medical devices. Quality management systems. Requirements for regulatory purposes.’ /
‘This standard sets out the key requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices as well as can be used by internal and external parties, including certification bodies to test an organization’s ability to meet both customer and regulatory requirements.’
Master Pharm Poland specializes in
- medical device designing
- medical devices manufacturing – we have manufacturer’s certification
- medical devices distribution
- medical device subcontracting
The Company’s Portfolio includes:
- Class I medical devices, which are not the subject to conformity assessment to obtain CE Mark. However, the product must comply with all the relevant requirements of MDD – Medical Devices Directive (93/42/EEC). Cooling Plasters Altacet Ice and Altacet Junior Gel are examples of class I devices.
- Class IIa and III medical devices, which require the manufacturer’s declaration of conformity with the provisions of the MDD and the Medical Devices Regulations 2002 and ensuring that their products comply with relevant essential requirements. The conformity assessment must be backed up by a notified body and CE marking.
Ketonal Termo Warming Plaster is an example of class IIa medical device. They are CE marked by notified body under No 0197 TUV Rheinland LGA Products GmbH.
The plasters have been the first product of this type on Polish market. They release warmth due to exothermic reaction which relaxes the muscles of upper back and shoulders.
In order to ensure the highest standards of patients’ safety Master Pharm Poland carries extra quality tests. The measurements of determining long term warming plaster temperature changes are carried out to determine the dependence of the changes and the time as well as measurements of warming temperature for each series. For this purpose a Measurement Laboratory has been designed, created and certified for this medical device. An author measurement system and software for processing data have been designed. To our knowledge, the laboratory of this type is the only one measuring centre for this type of medical device in Poland.
All the medical devices that are manufactured or distributed by Master Pharm Poland are registered with and under the jurisdiction of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
What Master Pharm can offer its clients?
Master Pharm Poland carries out the following processes:
- medical device designing
Designing a medical device requires its unequivocal complying with Medical Devices Directive (93/42/EEC) and carrying out conformity (to these standards) assessments procedures. Our company sets the requirements and quality aims with regards to the product related processes, such as implementing production and test processes, documentation, validation requirements, verification, monitoring, testing, research and recording.
The products must be designed and manufactured in such a way that ensures safe clinical conditions, patients’, or if applied, third parties’ health and safety if the product is used in accordance with its purpose and application. Conditionally, any risk that may occur can be acceptable and minor against benefits that will outweigh the risk and ensure a patient’s high level of health and safety protection.
- Carying medical devices testing
One of the medical devices requirements is carrying out testing of medical devices against relevant for these products norms under Medical Devices Directive (93/42/EEC).
Research and analyses projects take place in cooperation with scientific research centres, such as Politechnika Łódzka (Technical University of Lodz), National Medicines Institute, Institute of Pharmacology, Institute of Toxicology, Biochemistry and Bio pharmacy Institute, the National Institute of Public Health - National Institute of Hygiene (NIPH - NIH), National Research Institute of Mother and Child.
- Documentation – making / keeping records
A product realisation requires recording for evidencing that the realisation processes and the product itself will be up to relevant standards. Technical documentation, conformity, risk, clinical and risk assessments are carried out as well as the list of relevant requirements is compiled.
- Carrying Conformity Assessment Procedures to receive the CE mark
Master Pharm cooperates with notified bodies while carrying conformity assessments that are necessary to receive CE mark.
- Registering products with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.