Contract Medical International (CMI)

CMI Dresden moved to a new facility in December 2011

Tobias Rokosch — Thu, 22 Sep 2011 10:45:29 +0000

To ensure that we continue to offer valued services to our customers, we relocated our existing headquarters from Zur Wetterwarte 50, Haus 302, 01109 Dresden, Germany to our new premises at -

Contract Medical International GmbH
Lauensteiner Straße 37
01277 Dresden
Germany

Our business numbers and electronic address remain unchanged-

Telephone.: +49 351 213 88 88
Fax: +49 351 213 88 99
E-mail: info@contract-medical.com

Mail to our old address will be forwarded to the new facility until June 2012.

We advise you to contact your regulatory department, or us directly at Contract Medical International, to consider changes of your regulatory and other documentation, including device labeling.

We invite you to come and see our new facility and newly installed controlled environment room. We look forward to being of continued service to you and we hope you will enjoy the benefits of CMI at our new location.

CMI obtains new CE mark for irrigated EP catheter

Tobias Rokosch — Fri, 01 Jul 2011 13:07:05 +0000

CMI is proud to announce that on June 6th, 2011 we obtained a new CE mark with our partner Advanced Cardiac Therapeutics’ Tempasure™ Catheter System. ACT’s Temapasure™ Catheter System is a novel irrigated electrophysiology RF ablation catheter system which implements Veritas™ Technology to allow real-time tissue temperature measurement at depth. For the first time the true tissue temperature of tissue can be measured real-time during ablation with an irrigated ablation catheter. This system is the culmination of over 2 years of development and collaboration between CMI and ACT. CMI would like to thank the ACT team for all its hard work and wish ACT great success with its amazing new product.

For more information about ACT, please visit

http://www.contract-medical.com/products/instrumented-catheters/advanced-cardiac-therapeutics/

http://www.actmed.net/

Advanced Cardiac Therapeutics, Inc. (ACT) - First Clinical Trials

Tobias Rokosch — Mon, 16 May 2011 09:10:52 +0000

In March of 2011 Advanced Cardiac Therapeutics, Inc. (ACT) has enrolled the first patients into a clinical trial to assess the performance of the company’s RF cardiac ablation catheter. The study will consist of up to 30 patients with atrial flutter and will be conducted at multiple sites in both Europe and New Zealand. The TEMPASURE™ cardiac ablation catheter is the first to offer both saline irrigation and temperature sensing technology.

For more information about the clinical trials, please visit

http://finance.yahoo.com/news/Advanced-Cardiac-Therapeutics-bw-484907597.html?x=0

10th anniversary of CMI

Tobias Rokosch — Fri, 27 Aug 2010 13:35:19 +0000

We’re proud to announce that our company celebrated its 10th anniversary October 26th, 2010.

ACT at the CARDIOSTIM in France

Tobias Rokosch — Fri, 11 Jun 2010 09:29:22 +0000

Advanced Cardiac Therapeutics (ACT), who is working closely with CMI on a temperature controlled ablation catheter, is proud to be present at the CARDIOSTIM 2010 in France.

For more information about ACT, please visit

http://www.contract-medical.com/products/instrumented-catheters/advanced-cardiac-therapeutics/

as well as

http://www.actmed.net/

Full compliance with 2007/47/EC

Tobias Rokosch — Mon, 17 May 2010 07:38:35 +0000

Contract Medical International complies with the Medical Device Directive 93/42/EEC as last amended by Directive 2007/47/EC. The compliance has been confirmed by the KEMA Quality B.V. notified body. The new requirements have been applicable since 21 March 2010.

You can find the applicable quality system and product certificates here.

Job Opportunity - Manufacturing Engineer or Molding Technician for our Czech Facility

Tobias Rokosch — Tue, 06 Apr 2010 12:35:21 +0000

For our Czech Republic subsidiary we are looking for a Manufacturing Engineer (Plastics) or Molding Technician

In this position you will work closely with the manufacturing and development department in order to
Your main responsibility will be:

• Implementation of molding and forming processes into production
• Development of new processes to support development of new products.
• Planning and leading of transfers of new product lines into regular manufacturing.
• Process improvements in terms of time and scrap reduction

You should have:

• Degree in mechanical, biomedical or electrical engineering
• Experience with injection moulding required
• Excellent written and spoken English
• Experience with process improvements (capability of the processes, statistical process control, lean manufacturing etc.)
• Experience with medical industry as well as medical device related standards preferred

Travel requirements:

• The majority of the work will be spent on-site with regular travel activities abroad, especially to our Dresden subsidiary, which is our center for development
• Passenger cars driving license needed

We offer:
• environment of rapidly growing international company
• independent and challenging projects

Please send your application to jobs@contract-medical.com.

Please send your application to jobs@contract-medical.com

——————————————————————

Jsme mezinárodní spole?nost, zabývající se výrobou jemné léka?ské techniky, s pobo?kou v Hradci Králové, ?R a v Dráž?anech, N?mecko. Zabýváme se zakázkovou výrobou vysoce kvalitních výrobk? pro zdravotnictví, vývojem a poradenskými službami pro léka?ský pr?mysl.

Pro naši pobo?ku v Hradci Králové hledáme uchaze?e na pozici:

Výrobní inženýr (plasty) nebo
technik – vst?ikování plast?

Na této pozici budete úzce spolupracovat s výrobou a odd?lením vývoje za ú?elem zavád?ní nových výrobk? do sériové výroby.

Vaše hlavní nápl? práce bude:

• implementace proces? vst?ikování a formování plast? do výroby
• vývoj nových proces? na podporu vývoje nových výrobk?
• plánování a vedení transfer? nových výrobk? do sériové výroby
• vylepšování stávajících proces? za ú?elem snižování výrobních ?as? a zmetkovosti, zvyšování efektivity výroby

Požadujeme:

• vysokoškolské nebo st?edoškolské vzd?lání technického sm?ru
• praxe v oblasti vst?ikování plast? podmínkou
• výborná znalost AJ slovem i písmem
• zkušenost s vylepšováním výrobních proces? (statistické ?ízení proces? atd.)
• ?idi?ský pr?kaz sk. B
• samostanost, proaktivní p?ístup k ?ešení problém?

Hlavní pracovní pom?r bude v Hradci Králové s ob?asnými pracovními cestami do zahrani?í, p?edevším do naší pobo?ky v Dráž?anech, kde je centrum pro vývoj výrobk? a také nástrojárna.

Nabízíme:

• r?znorodou práci v mezinárodní spole?nosti v rychle rostoucím pr?myslovém sektoru
• samostatnou práci na zajímavých projektech
• možnost seberealizace v dynamickém prost?edí

CMI complies with CAN/CSA ISO 13485

Tobias Rokosch — Thu, 04 Mar 2010 17:16:37 +0000

CMI has received CAN/CSA ISO 13485 certificate which is required by the Canadian medical device authorities from manufactures to be able to place their devices into the market in Canada.
CMI pursued the CAN/CSA ISO 13485 certificate as part of an ongoing commitment to achieve compliance with the regulatory requirements of the global medical community.
The certificate was issued by KEMA Quality who is a recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS) as well as one of the leading Notified Bodies worldwide.

You can find all updated certificates here

All CMI CE certificates upgraded to Annex II

Tobias Rokosch — Wed, 13 Jan 2010 08:45:04 +0000

We are proud to announce that all Contract Medical International device CE certificates have been upgraded to the Annex II (Full Quality Assurance System) Conformity Assessment Procedure of the Council Directive 93/42/EEC by KEMA Quality notified body.

Annex II capability gives CMI the ability to act as its own ‘Notified Body’, and such as, has the most latitude allowed under the Medical Device Directive.

You can find all updated certificates here

Association with the new medical device accelerator in Europe (MDA)

Tobias Rokosch — Tue, 27 Oct 2009 09:20:20 +0000

CMI is proud to be associated with the new medical device accelerator in Europe (MDA). Based at the Science Park next to Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland, MDA aims to accelerate the development of revolutionary medical device technology ideas in Europe and to create entities ready for future financing or licensing.

With the launch of MDA, European inventors now have the opportunity to transform their medical technology ideas into reality, through the investment of engineering, legal, and commercial expertise.

Backed by corporate and venture capital from Europe, MDA aims to leverage the competencies of its partners to bring ideas that pass the initial screening process, through proof of concept, to new company incorporation and preparation for external funding.

MDA is financially backed by its founders, Paris-based independent Venture Capital firm Sofinnova Partners and global medical device leader Medtronic Inc. and supported by its partners, European-based contract medical device manufacturing specialists CMI (Contract Medical, International) and Valtronic Technologies.

For more information about MDA, please check

http://www.mdaccelerator.com