Contract Medical International (CMI)

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

Trainees passed their exam

Tobias Rokosch — Tue, 08 Sep 2009 10:38:07 +0000

We are proud to announce that both of our Dresden trainees successfully passed their exams this summer and we now have two fully trained accountants who work in accounting and customer service. Our congrats to Odette Frenzel and Manuela Habich.

New Manufacturing Engineer Jens Gnauck

Tobias Rokosch — Tue, 08 Sep 2009 10:34:58 +0000

In mid July 2009 Jens Gnauck joined CMI as a Manufacturing engineer. At the same time Lukas Roupec moved on to a new challenge to lead the manufacturing engineering department company wide out of our Czech facility.

3rd Cleanroom in Hradec Kralove Facility completed

Tobias Rokosch — Mon, 06 Apr 2009 14:10:22 +0000

Contract Medical International GmbH’s 3rd cleanroom has been completed and fully validated.

The facts:

class 100 000 clean room -> ISO classification Class 8
220 m² (including pass through and gowning room) -> production area 190 m²

With the addition of the 3rd cleanroom, CMI’s capabilities for production have been increased and we are now able to be more flexible in accepting different manufacturing orders.

New Documentation Specialist Denise Herklotz

Tobias Rokosch — Tue, 06 Jan 2009 10:23:00 +0000

In 2009 Denise Herklotz joined our Dresden facility Documentation Group as a Documentation Specialist. In her role she will be responsible for creation of Device Master Records for various manufacturing and development projects. Denise has previous experience from other CMI departments where she had worked before her maternity leave.

New Technical Writer Jana Gosz

Tobias Rokosch — Tue, 06 Jan 2009 08:32:00 +0000

In December 2008 JANA GOSZ joined CMI’s Regulatory Affairs & Quality Assurance team as a Technical Writer. Her main responsibility will be to create and maintain device technical dossiers for EU CE mark in close cooperation with the engineering group. We wish Jana a successful career with CMI.

Routine FDA Audit passed without non-conformities

Tobias Rokosch — Wed, 10 Sep 2008 07:07:29 +0000

On 15-17 July 2008 FDA performed a routine inspection to CMI covering FDA’s Quality System/Current Good Manufacturing Practice Regulations for Medical Devices (21 CFR Part 820). This audit was a part of FDA’s effort to inspect foreign manufacturers that export their products to the United States.

Previous audit to CMI was in 2004. CMI successfully passed the FDA inspection with no non-conformances and without the issuance of a form FDA 483, Inspectional Observations.

We are all pleased that our Quality Management System continues to meet or exceed the highest standards in the industry.

New Regulatory and Quality Affairs Administrator

Tobias Rokosch — Thu, 04 Sep 2008 08:53:08 +0000

In July Ondrej Tomsa joined the CMI team as new HK-based Regulatory and Quality Affairs Administrator. His previous experience include working in quality departments of several manufacturing companies, one of them was Panasonic. At CMI he will be mainly responsible for QC inspections, quality feedback to suppliers and training system.