BLOG

16Jul, 2020

“Community mask” Guidelines

By: | Tags: , , , , , , ,

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 […]
READ MORE

6Apr, 2020

Conformity assessment procedures for 3D printed products to be used in a medical context for COVID-19

By: | Tags:

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 […]
READ MORE

23Jan, 2020

We are now ISO 9001:2015 certified!

By: | Tags:

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  
READ MORE

16Dec, 2019

Internet of Medical Things (IoMT)

By: | Tags:

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, […]
READ MORE

3Jun, 2019

Accreditation of medical laboratories according to ISO 15189 standard

By: | Tags: ,

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 […]
READ MORE

14May, 2019

The deadline has expired – Implementation of new standard revision ISO 13485:2016 is mandatory now

By: | Tags:

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 […]
READ MORE

12Oct, 2017

Managing the Transition to ISO9001:2015

By: | Tags:

Deadline for transition to the new requirements of ISO 9001:2015 standard is September 2018., where is expected of all certified organizations to complete this process and have valid certificates. Transition to the new revision consider new requirements implementation in the following areas: 1. Leadership 2. Context of the organization 3. Interested parties 4. Opportunities and Risk management 5. Change management system 6. Organizational knowledge 7. The Standard structure 8. Documented information, etc. QualityCert Ltd. provides support in understanding and implementation of the new ISO 9001:2015 standard requirements in your business […]
READ MORE

error: