About Irene Perovsek

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So far Irene Perovsek has created 21 blog entries.

October 2019

21 CFR 820, ISO 13485:2016 and MDR – Are you prepared for the changes ahead?

By |2019-10-24T15:59:04+01:00October 24th, 2019|Medical Device, Non classé, Quality|

Medical device manufacturing and marketing in the U.S.A. is regulated by the FDA. Medical device manufacturers must register with the FDA and produce their products with a Quality System that meets the FDA Quality System Regulation and more precisely with the 21 CFR 820. Compliance with regulations is crucial and requires an investment of both […]

Mike Labbe, Director of R&D at Valtronic Technologies USA Inc. interviewed by MPO Magazine

By |2019-10-16T17:32:51+01:00October 16th, 2019|News|

MPO (Medical Product Outsourcing) Magazine published an article about the factors and trends influencing the custom medical electronics market. Topics discussed include:

  • Challenges in medical device design and manufacturing,
  • Regulations,
  • Customer expectations regarding custom electronic components,
  • The trend towards miniaturization,
  • The increasing demand for full turnkey services.

Mike Labbe, Director of R&D at Valtronic USA, with […]

September 2019

Supporting our Customers with the new MDR

By |2019-09-12T14:55:26+01:00September 12th, 2019|Non classé|

The Medical Device Regulation (MDR) will replace the MDD on 26 May 2020. Medical device legal manufacturers are now in various stages of addressing the many changes implied by the new European Regulation. Main changes are product scope expansion, reclassification of devices, more rigorous clinical evidence, recertification of currently approved devices and the use of […]

May 2019

Portrait of Dr. Lepple-Wienhues, Head of New Technologies.

By |2019-07-05T12:12:25+01:00May 29th, 2019|General, Healthcare, Innovation, Medical Device|

“With my medical background and experience in operating rooms, I can identify practical issues when developing a medical device.” – Portrait of Dr. Albrecht Lepple-Wienhues, Head of New Technologies.

Innovating in medical devices requires knowledge of the medical field and many years of experience. For Albrecht Lepple-Wienhues, Head of New Technologies at Valtronic Switzerland, the question […]

April 2019

What customers say about Valtronic – Aleva Neurotherapeutics SA

By |2019-07-05T12:13:45+01:00April 10th, 2019|Contract Manufacturing, General, Healthcare, Medical Device|

Aleva Neurotherapeutics SA is developing the next generation of implantable Directional Deep Brain Stimulation (DBS) system. These implants help patients with Parkinson’s disease control symptoms such as tremor. Aleva’s Neurotherapeutics directSTIM™ system is unique as its directional stimulation allows the area of the brain to be treated with targeted precision. This will improve therapeutic response […]

Portrait of young and talented engineer Jessica Monsman

By |2019-07-12T11:11:05+01:00April 1st, 2019|Contract Manufacturing, Engineering, General, Medical Device|

“We help our customers improve the design of their medical device for improved manufacturability.” – Portrait of young and talented engineer Jessica Monsman

When customers are sub-contracting the design, industrialization and manufacturing of their medical device to Valtronic, a multi-disciplinary team ensures a seamless process. The success of Valtronic is to a large extent due to […]

March 2019

ISO 9001 versus ISO 13485

By |2019-07-05T12:15:45+01:00March 7th, 2019|General, Medical Device, Quality|

ISO 9001 versus ISO 13485 – What are the differences and which certification is best adapted to medical devices manufacturers?

Developing products with highest quality standards is essential for medical device manufacturers. Having been certified to both ISO 9001 and ISO 13485 for the past decade, Valtronic and quality manufacturing are long time companions. However, is […]

Valtronic Adds Two New Juki Machines to Meet Growth Demands

By |2019-07-16T10:42:51+01:00March 1st, 2019|News|

Cleveland, OH March 2019 – Valtronic, an EMS manufacturer focusing on medical devices, recently invested in two new Juki 3020 SMT pick-and-place machines expanding its SMT lines to meet growth demands. These additions will provide flexibility, depth and breadth to the company’s manufacturing lines.

With the addition of these machines Valtronic now has two complete lines […]