MedtecLIVE

GMED

GMED and its subsidiaries GMED North America and LNE-GMED UK support manufacturers of medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs) in their certification projects, whatever the level of product risk or innovative technologies used.

Paris, France

cetecom advanced GmbH

cetecom advanced is your globally active, independent testing and certification service provider – a leader in the field of market approvals in the telecommunications and information technology sector.

Saarbruecken, Germany

Elektrisola Feindraht AG - Elektrisola Medical Technologies

Elektrisola Feindraht AG develops and produces enameled wire specialties in medical grade quality. The PI and PA coated standard and precious metals are used throughout the medical industry. Our ISO 13485 certification guarantees a consistently traceable process!

Escholzmatt, Switzerland

STAINLESS FRÜCHTL GmBh

STAINLESS Group provides a wide range of high-quality metallic grades and services to medical device manufacturers, particularly those producing orthopedic, trauma, spine, stent and dental implants, their ancillaries and surgical instruments.

Esslingen, Germany

Berlin Cert GmbH

Certification of QMS in accordance with DIN EN ISO 13485 and conformity assessment procedures in accordance with MDR We have been inspecting and auditing medical technology companies since 1997. In this way, we play our part in ensuring that the European requirements for safe and effective medical d

Berlin, Germany

TÜV SÜD Product Service GmbH

TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.

München, Germany

KANEKO Manufacturing Co., Ltd.

KANEKO has over 60 years experience in machining of metal, resin, ceramic and, assembly of high-precision components. With over 40 years experience in the endoscopic field and, 30 years experience in aviation field, KANEKO always provides the best solution and result.

Saitama, Japan

BAYOOSOFT GmbH

Focus on the essentials and increase productivity. Simplify, delegate & automate your management processes in highly regulated areas and critical infrastructures.

Darmstadt, Germany

Posts related to 'Certification' (44)

mdc medical device certification GmbH

May 6, 2024

Services for the CE certification of medical devices

CE Marking MDR (EU) 2017/745: Regulation (EU) 2017/745 on medical devices (EU Medical Device Regulation) is the medical device law that manufacturers must comply with in order to place medical devices on the European market.

mdc medical device certification GmbH

May 7, 2024

Market & Industry

Services for the CE certification of in-vitro diagnostics

Regulation (EU) 2017/746 on medical devices: The IVDR regulation is the applicable regulatory basis for in-vitro diagnostics (IVD) on the European market.

Lesjöfors Springs & Pressings

May 16, 2024

Market & Industry

Lesjöfors Group, in China, achieves ISO medical industry certification

The Lesjöfors Group’s manufacturing plant in Changzhou, China, has passed the certification process for ISO 13485 - the medical industry's optimal medical device standard.

GMED

April 29, 2024

Accompanying you in the transition to the European Medical Device Regulation

GMED, and its subsidiaries GMED North America and LNE-GMED UK, provide comprehensive solutions to support you throughout the certification of your medical devices (MDs) and in vitro diagnostic medical devices (IVDs).

TRUMPF Laser- und Systemtechnik AG

February 19, 2024

Support throughout the qualification process

Would you like to use your laser systems to manufacture products in an environment subject to certification requirements? Our experts support you during the qualification process.

mdc medical device certification GmbH

April 10, 2024

Our seminars - quality and expertise

From practice for practice - benefit from decades of experience as a Notified Body in our public seminars. In the field of quality management and regulatory issues, we convey the current requirements of EU regulations, EC directives, national laws and standards.

mdc medical device certification GmbH

April 12, 2024

Market & Industry

An urgent call to action for medical device manufacturers

As of March 20, 2023, Regulation (EU) 2023/607 was published to smoothen the transition from MDD (and AIMDD) to MDR certification of devices on the market and to assure availability of medical devices on the European market.

JÜKE Systemtechnik GmbH

February 19, 2024

Regulatory Affairs

Benefit from the extensive and long-standing experience of our experts: We accompany the entire process, from consulting to approval requirements, standard-compliant development and production through to the certification of medical devices.

MedtecLIVE

February 21, 2024

Best practice

Valuable tips on how to navigate through the regulatory jungle

At MedtecLIVE 2023 in Nuremberg, Steffen Eschinger, strategy consultant for medical technology companies, reported on which procedures have proven to be effective for the (re)certification of medical devices and which pitfalls should be avoided at all costs.

GMED

April 29, 2024

LNE-GMED UK, newly designated as an Approved Body under UK Medical Device Regulations

Previously designated as an Approved Body for non-medical regulations since October 2022, LNE-GMED UK, a GMED subsidiary of the LNE Group, has expanded its services to medical devices since January 2024 and can now offer certification services in this field.