30. November 2021

Qmedics has obtained the Good Manufacturing Practices (GMP) certificate for its quality control, cleanroom facility and medical device manufacturing activities at its Swiss-based facility in Zürich- Flurlingen in November 2021

Qmedics has received the certification from the Regulatory Authority of Brazil, ANVISA (Agência Nacional de Vigilância Sanitária, Brazilian Health Surveillance Agency) following an inspection and audit of our quality system, cleanroom facility and manufacturing. This certification has been achieved without any findings.

Qmedics has obtained the Good Manufacturing Practices (GMP) certificate for its quality control, cleanroom facility and medical device manufacturing activities at its Swiss-based facility in Zürich- Flurlingen in November 2021I am very pleased that Qmedics AG has been able to achieve the GMP certification. A GMP certification in general is granted to companies whose production facilities demonstrate a high degree of quality and consistency in their manufacturing procedures.

Prof.Dr.med Patteet Anita CEO of QMedics attributed this accomplishment to the hard work of Qmedics production, R&D and Quality team and their dedication to ensure that Qmedics cleanroom, production facility, quality system and R&D design history files complies with the most stringent standards. This certification enables us to continue in our global growth strategy and fulfill contracts in the Brazilian and EU market.

Given the other challenges surrounding the COVID – 19 Pandemic, it was stated not so much request were there for GMP certifications (Current Good Manufacturing Practices)
certificate in 2021. However, Qmedics as an OEM and Legal manufacturer of medical devices who prioritize safety, quality, product integrity, and operational excellence was determined to complete the GMP submission with a certification end 2021.

Quality management is an integral philosophy for consistently improving the quality of manufactured medical device products. Together with the development of our new product portfolio (SDS Family EXIST, FALCOR and DRACO) we took on the challenge to adapt our quality and production management system to become compliant with the GMP requirements that will bring an enhancement in product and production safety what serves at the end the wellbeing of our patients.

For Qmedics the implementation of GMP requirements is enormously important for the manufacturing and quality process because it ensures a level of quality, safety, purity, and strength in any products that are released to the public.
The implementation of the compliance with the GMP took Qmedics practically a full year starting with:

  • Taking the existing quality system that ensures every Qmedics product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness up to the cGMP level. Especially given attention to the assessment and mitigation of risk, and the change control and CAPA processes.
  • Updating the designing and developing processes of Qmedics products and associated manufacturing processes to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.
  • Implementing systems to maintain compliance with Current Good Manufacturing Practices and Quality System regulations

Now Qmedics operates a state-of-the-art Good Manufacturing Practice (GMP) production facility.

We are proud to be one of the few medical device legal and contracted manufacturers in Switzerland to have received this certification,” said Prof.Dr. med. Patteet Anita CEO of Qmedics.

Going further with the commend-: “This certification will allow Qmedics to produce our own state of the art product portfolio under the highest quality regulations, and facilitate the business in EU, middle east and Brazil on one hand – but on the other hand we can be seen as a perfect partner for contracted manufacturer for medical devices.

Qmedics has obtained the Good Manufacturing Practices (GMP) certificate for its quality control, cleanroom facility and medical device manufacturing activities at its Swiss-based facility in Zürich- Flurlingen in November 2021

2022
31. May 2022

First public announcement of the Horizon trial , were Qmedics “back to the basics concept” with the innovative stent design that takes into account both movability and lesion characteristics.

Treatment of the Femoro-Popliteal district with the innovative Exist NiTi Stent (QMEDICS) type Flex & Pull: the HORIZON clinical trial. Marone E.M.1, Rinaldi …

28. February 2022

Qmedics is proud to announce the first Enrolment in the “HORIZON” trial for the Treatment of PAD

The Horizon study will provide information on the long-term outcomes of the innovative EXIST NiTi self- expandable stent with its two types of …


2021
19. May 2021

Our publication Safety and Efficacy of Peripheral Embolization with EASYX Liquid Embolic Agent: A multicenter Prospective Study was accepted by the Journal of Vascular Interventional Radiology.

The use of cyanoacrylates, used for embolization for a long period of time, has decreased in the last decades, they are currently still …

28. February 2021

First EasyX Case report in Nicosia General Hospital, Cyprus

A 64-year Old patient presented to the nephrostomy department of Nicosia General Hospital with chronic allograft nephropathy and elevation of the inflammatory markers …

31. January 2021

A milestone reached EASYX I trial closed successfully

COVID-19 has created challenges in every aspects of healthcare. Due to the current pandemic, the medical device industry has been under tremendous pressure …


2020
31. August 2020

Qmedics Peripheral stent system family

After two and a half years of hard work finally we present the new peripheral stent family. It was a difficult path: The …

30. July 2020

PTA Qmedics product family Manatee-Naga-Nova is launched

The rise in the prevalence of cardiovascular diseases and peripheral vascular diseases, adaptation to a sedentary lifestyle, better healthcare facilities are key factors …


2019
30. September 2019

Qmedics achieved to close with success the first investigator meeting

“Horizon” Clinical investigation of the Qmedics Exist NiTi Stent portfolio with the Flex & Pull type in adults with Peripheral Artery Disease (PAD). …

31. July 2019

NEW PRODUCT added to our Portfolio

The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access …


2018
31. October 2018

New Organization for Qmedics

In 2016 the Board of Directors decided to sell the sister company of Qmedics, who was at the same time the biggest customer …

28. September 2018

Qmedics team at Cirse

Our travel did start with a strike of the taxi drivers, a delay in our shipment of workshop material- but as a team …

31. July 2018

First workshop: Endovascular treatments of PAD

With the organization of workshops the professionals get to understand the two stent types “ Pull & Flex”. The first workshop “Endovascular treatments …

30. March 2018

Exist & Manatee launched in “Der Schweiz”

As a Swiss company we are very pleased that our improved QM1 “Exist” a product entirely developed at our facility “made in Switzerland” …

3. January 2018

LINC congress: Presentation of our innovative product portfolio

Already a whole year qmedics R&D engineers are working on this concept and with success. The Finite element analysis (FEA), the bench testing …


2017
22. December 2017

Qmedics receives DIN EN ISO 13485:2016 Certificate

Qmedics is proud to announce its DIN EN ISO 13485:2016 certification. The company is now in the right to develop, manufacture and market …


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