knoell Germany GmbH aus Mannheim auf der COMPAMED 2019 in Düsseldorf -- COMPAMED Messe
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Dienstleister

knoell Germany GmbH

Konrad-Zuse-Ring 25, 68163 Mannheim
Deutschland
Telefon +49 621 718858-0
Fax +49 621 718858-100
info@knoell.com

Hallenplan

COMPAMED 2019 Hallenplan (Halle 8a): Stand C31

Geländeplan

COMPAMED 2019 Geländeplan: Halle 8a

Ansprechpartner

Dr. med. Isabelle Lang-Zwosta

Group Leader Health Care

Telefon
+49 151 17222101

E-Mail
ilang@knoell.com

Maik Endler

Director

Telefon
+55 (11) 98917-3685

E-Mail
mendler@knoell.com

Besuchen Sie uns!

Halle 8a / C31

19.11.2019

Thema

11:00 - 11:30

Join our lecture in Hall 8b G40

Lacey Chessor: What to expect when you are not expecting... the FDA

Mehr Weniger

14:00 - 14:30

Join our lecture in Hall 8b G40

Vera Naumburger: Regulatory requirements for the development of Medical Device software

Mehr Weniger

20.11.2019

Thema

14:00 - 14:30

Join our lecture in Hall 8b G40

Diego Louzada: Medical Device Registration: Good news from Brazil

Mehr Weniger

21.11.2019

Thema

11:00 - 11:30

Join our lecture in Hall 8b G40

Peggy Synwoldt: IVD Regulation: Hands-on strategies for your way into a new area 

Mehr Weniger

Unser Angebot

Produktkategorien

  • 02  Endproduktefertigung
  • 02.15  In-vitro-Diagnostik (IVD)

In-vitro-Diagnostik (IVD)

  • 03  Dienstleistungen
  • 03.02  Beratung
  • 03.02.07  Medizinproduktezulassung
  • 03  Dienstleistungen
  • 03.09  Prüfdienstleistungen
  • 03.09.06  Auditierung

Auditierung

  • 09  Software, IT
  • 09.04  Software als Medizinprodukt

Software als Medizinprodukt

Unsere Produkte

Produktkategorie: Medizinproduktezulassung

Fast and successful access to your key markets

As an independent globally operating consultancy, knoell's international team of more than 20 medical device experts includes specialists in biomedical engineering, software engineering, medical sciences and medical writing, pharmacology, toxicology, chemistry and biochemistry.

We support manufacturers of medical devices and IVDs with our extensive expertise at every point of the product life cycle. Our medical device experts support you in gaining access to global key markets like Europe, North & South America and Asia.

Together with our clients we build a sound market access strategy by identifying the most efficient route to place your products on the desired market.

You are looking for support with design, risk or usability documentation, for advice regarding biological or clinical safety or your quality management topics? At knoell, you will find all this - support from a single source.

Strengthen your know-how
Additionally we provide advanced trainings on:

  • Regulatory requirements for product registration in global key markets (Europe, Asia, North & South America)
  • FDA inspections
  • Strategies to get hands-on experience for conducting biological evaluations (10993-series, biological safety assessments, toxicological risk assessments), clinical evaluations of medical devices (MEDDEV 2.7.1 Rev 4, 2017/745) and IVDs (2017/746).
To view our complete training schedule please check our knoell academy portfolio (see link below).

Mehr Weniger

Über uns

Firmenporträt

Fast and successful access to your key markets

As an independent globally operating consultancy, knoell's international team of more than 20 medical device experts includes specialists in biomedical engineering, software engineering, medical sciences and medical writing, pharmacology, toxicology, chemistry and biochemistry.

We support manufacturers of medical devices and in vitro diagnostic medical devices (IVD) with our extensive expertise at every point of the product life cycle. Our medical device experts support you in gaining access to global key markets like Europe, North & South America and Asia.

Together with our clients we build a sound market access strategy by identifying the most efficient route to place your products on the desired market.

You are looking for support with design, risk or usability documentation, for advice regarding biological or clinical safety or your quality management topics? At knoell, you will find all this - support from a single source.

Strengthen your know-how

Additionally we provide advanced trainings on:
  • Regulatory requirements for product registration in global key markets
  • FDA inspections
  • Strategies to get hands-on experience for conducting biological evaluations (10993-series, biological safety assessments, toxicological risk assessments), clinical evaluations of medical devices (2017/745, MEDDEV 2.7.1 Rev 4) and IVDs (2017/746).


Mehr Weniger

Unternehmensdaten

Anzahl der Beschäftigten

500-999

Geschäftsfelder

Dienstleistungen