Medical Devices and in-vitro diagnostic Medical Devices (IVDs)

Stay compliant - even in these difficult times

With coronavirus changing not only our social life but also our business operations dramatically, remote auditing might be the answer for you to keep your business compliant and to get a headstart on your competitors once the situation changes back to business as usual.

 

So what exactly is remote auditing?
In contrast to the common audit, where the auditor visits the client and performs the audit locally, with remote audits the major contact between auditor and client is via skype, phone and internet. This does not only apply to communication, but also to performing certain packages of the audit. Further benefits apart from avoiding personal contact in these times, are higher flexibility, lower costs and direct preparation of digital evidence. These advantages clearly outweigh the disadvantage a lack in personal contact between auditor and auditee might  be seen as.

At knoell we have substantial experience with performing complex remote audits and can guarantee a stable and secure technical infrastructure.

Request further information or arrange for an appointment to discuss your particular situation here.

 

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.

Dr. med. Isabelle Lang-Zwosta Global Regulatory Affairs and Business Development Medical Devices
+1 615 374 1242 send mail

A global network for medical devices

Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!