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12Jan, 2023
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Auditor’s desired attributes and professional behavior

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Introduction This article introduce Guidelines for auditing management systems (ISO 19011:2018) in particular it is providing an overview of desired attributes and professional behavior of individuals conducting the audit of management systems. Confidence in the audit process and the ability to achieve its objective depends on the competence, attributes, personal behavior and skills of auditors as well as the experts supporting the audit team. Auditing profession relies on consistent adherence to auditing principles as described below and there is no excuse if those are not followed. Professional behavior described in […]
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4Jul, 2022
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EN 15224 Quality management systems – EN ISO 9001:2015 for Healthcare

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What is standard EN 15224? This European Standard specifies requirements for a quality management system of healthcare organization. It brings together the advantages of ISO 9001 with comprehensive healthcare quality requirements, focusing on patient safety and management of clinical processes and risks. The term “clinical” refers to all means of interaction between patients and health care staff. Scope Like other management standards, this standard focuses on processes, where requirements related to material outputs such as tissue, blood products, pharmaceuticals or medical devices have not been focused in the scope of […]
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8Jun, 2021
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Questions & Answers on MDR “Custom-Made Devices”

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  What is a custom-made device? MDR Article 2 (3) defines a „custom-made device“ as any device that: is specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications; which gives specific design characteristics provided under that person’s responsibility and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.   Examples can include devices made in accordance with a written prescription: Hand prosthesis An orthosis Orthopedic footwear   Devices […]
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24Jan, 2021
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QualityCert Web App – MDR Classificator – Medical devices classification according to the EU Medical Device Regulation (EU MDR 2017/745)

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  MDR Classificator QualityCert Ltd. introduces unique web application, the “MDR Classificator”, provided as a tool for medical device industry stakeholders, primarily for Manufacturers, as well as others involved in regulatory processes where medical device classification is taking place. The MDR Classificator is based on the MDR (EU Medical Device Regulation 2017/745) classification requirements and rules structure. MDR Classificator has been released in Beta 1 version and it is generic questionnaire that mirrors the statements of MDR Annex VIII, Chapter III Classification rules. With a solid understanding of the classification […]
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16Jul, 2020
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“Community mask” Guidelines

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New EU common Guideline for “Community mask” CWA 17553:2020 Community face coverings – Guide to minimum requirements, methods of testing and use (LINK).   Due to high demand and in shortage of medical and protective face masks during COVID-19 pandemic, WHO promotes Community mask to be used by people not displaying any clinical symptoms of viral or bacterial infection and who do not come into contact with people displaying such symptoms. Apparently Community mask is a new product that so far has not been regulated on the market by EU/EEA […]
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6Apr, 2020
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Conformity assessment procedures for 3D printed products to be used in a medical context for COVID-19

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Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19. The European Commission has just released a guidance to assist manufacturers in ramping up production of essential medical equipment and material in above mentioned context. 3D Printers are NOT medical devices on their own, however such equipment need to comply with EU Machinery Directive 2006/42/EC and other applicable regulation, in order to be used for the purpose. 3D Printed product may constitute a medical device that fall under framework of Medical […]
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23Jan, 2020
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We are now ISO 9001:2015 certified!

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QualityCert Ltd. has been awarded ISO 9001:2015 certification for medical devices consulting and product engineering services. QMS scopes included in the certification: Management systems and medical devices development consulting. Product engineering, production and testing services. Quality and regulatory affairs education and seminars. There are numerous benefits of Quality Management System implementation and ISO certification at our Company, thus we looking forward for all stakeholders, in particular our customers, to benefit from it. Certificate preview  
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16Dec, 2019
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Internet of Medical Things (IoMT)

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Internet of Medical Things (IoMT) – critical subgroup of well-established Internet of Things (IoT) technology. IoMT are considered to be medical devices with computer networks connectivity features. Such medical devices bring significant potential for improved healthcare system and patient care. The IoMT have been found in current as well as in developing connected medical technologies. The following is an overview  of such applications with essential examples: wearable biosensors (smart lenses, pulse oximeters, glucometers, blood pressure, Holters, etc.) ingestible biosensors (“smart pill” for pH, temperature, pressure, gases, bacteria engineered, medication monitoring, […]
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3Jun, 2019
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Accreditation of medical laboratories according to ISO 15189 standard

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Accreditation, globally, has become a generally accepted way of managing quality and confirming the technical capability of medical laboratories. International Standard ISO 15189 defines the requirements that a medical laboratory must fulfill in terms of quality systems and competence, and the fulfillment of these requirements is verified by a National Accreditation Body (NAB). Accreditation per this standard applies to all medical laboratories for biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological and other examinations of human material. Such laboratory examinations are carried out for the purpose of providing information […]
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14May, 2019
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The deadline has expired – Implementation of new standard revision ISO 13485:2016 is mandatory now

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As of March 31st, 2019, the transition period for adoption of new standard’s revision ISO 13485:2016 has expired, as it was required by IAF Resolution 2015-13. On this date, the ISO 13485:2003 (incl. EN ISO 13485:2012) certificates became obsolete, and ISO13485 revision 2016 certificates are put in force and mandatory now. International standard ISO 13485 has been provided for quality management systems in medical devices. By implementation of this standard, manufacturers and other organizations involved in medical device lifecycle, achieve regulatory compliance, in the communities where this standard has been […]
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