Premium Exhibitor

Dr. Knoell Consult GmbH

Dynamostr. 19 , 68165 Mannheim
Germany

Telephone +49 621 718858-0
Fax +49 621 718858-100
info@knoell.com

This company is co-exhibitor of
Forum Medtech Pharma e.V.

Trade fair hall

  • Hall 3 / E92
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 3): stand E92

Fairground map

MEDICA 2016 fairground map: Hall 3

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses

Reports and analyses

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07.01.03  Evaluations

Evaluations

  • 07  Medical Services and Publications
  • 07.02  Further education and training

Further education and training

  • 07  Medical Services and Publications
  • 07.02  Further education and training
  • 07.02.01  Education and further education institutions

Education and further education institutions

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.01  Biocompatibility testings

Biocompatibility testings

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Reports and analyses, Evaluations, Further education and training, Education and further education institutions, Technical equipment management, Test houses / Certification Bodies, Biocompatibility testings, Certification and testing of medical devices, quality assurance

Medical Devices

The legal framework for medical devices is determined in the EU by the Medical Devices Directive 93/42/EEC (MDD). This divides medical devices – based on their hazard potential – into four classes (I, II a, II b, III). We advise you with the classification and assist in compiling the technical and regulatory documentation. The classification of your "borderline products" is also in good hands with our specialists.

Good international support network
With our subsidiaries and partners we are in a position to open up the global market for worldwide registration of your products. 

Well planned from the outset
In preclinical and clinical development, we perform the strategic study planning, coordination of the studies and the scientific evaluation of the results on your behalf. Our experts prepare assessments of the biocompatibility of your products as well as detailed toxicological expert reports.

Reliably obtaining the seal of quality
To make sure you obtain the CE Marking for your medical devices, we offer you an in-depth consultancy service and guide you purposefully through the different steps (e.g. confirmation, consultation procedure). We establish contacts and conduct negotiations with the notified bodies and competent authorities. We also offer you strategic and regulatory advisory support with the labelling of medical devices.

Our services at a glance
Strategic and regulatory consulting (also on-site) for worldwide registration
Classification of Medical Devices, In-Vitro-Diagnostica and borderline products
Clinical and biological evaluation, toxicological characterization
AuditingAudit trails for ISO 13485, GMP, QSR and medical device directives
Supplier audits
Perform "friend of the company" QSR compliance audits
Manage and respond to FDA and ISO 13485 audits to rectify observed deficiencies
Develop and implement QSR and ISO compliance programs customized to company operations
Review / preparation on technical documentation filesWorldwide product certification / registration please click here.
Design dossiers
Gap analysis of existing documentation
Bill of material structure and product configurations
Risk management accord. EN ISO 14971
Agency servicesInteraction with Notified Bodies or Authorities
EAR and US agent service
Production and R&DEstablishment registration and device listings
Validate products and processes
Design controls, corrective action, monitoring and trending programs
Reduction of product costs
Training onEuropean, Canadian and FDA medical device regulations
ISO 13485, ISO 9001 and GMP requirements
Country specific requirements

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About us

Company details

Wherever there is an attractive market, we are there for you!
 
As one of the leading specialists in the worldwide registration of chemical products and substances, we support our customers in the complex process of obtaining marketing authorisation in the respective markets.

Our approach: Markets are like companies. Despite all the common features, each has its own character. We do justice to this fact with our unique range of services.

Our positioning: We see ourselves as a specialist in all matters relating to regulatory affairs, product safety and consulting.

Our values: Respect and trust is the basis of our cooperation. Integrity, absolute quality orientation and the highest standards applied to ourselves are hallmarks of our activity.

Your benefit: Our employees have great scientific expertise in all areas. This allows us to respond extremely flexibly to your individual requirements, regardless of whether you require support from technical specialists or interdisciplinary teams. Together, we will design optimal individual solutions for you.

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