Meddevice Archives - Schlafender Hase

4 minutes read

The medical device sector’s surging regulatory burden: how are suppliers coping?

2 minutes read

Embracing e-Labeling in a global context

As the world shifts towards electronically delivered e-Labeling, it's essential to stay ahead of the game. Regulatory Authorities are now permitting and encouraging online e-PIL content, with other regions follow suit.

2 minutes read

TOPRA Sponsored Webcast: A Non-Technical AI Introduction for Regulatory Affairs Professionals

AI is already being used in many Life Science applications, meanwhile Health Authorities are looking to regulate the use of AI. As a regulatory affair professional, it is essential to have an understanding of this technology. In this general introduction to the field of AI, different uses of the term "Artificial Intelligence" will be discussed, and which might be desirable in a given context.

3 minutes read

9 Reasons Proofreading in Life Sciences Can Be a Nightmare

Risks, stress and more – there’s a lot at stake when you proofread in regulated industries. Here are nine reasons why proofreading in life sciences can be a nightmare.

< 1 minute read

A Buyer’s Guide to Purchasing Proofreading Software

Have you identified the need for a solution to compare text and graphics in your organization, but need some help with the complete process of identifying, evaluating, and acquiring the right solution?

2 minutes read

How to Build a Business Case for Document Comparison Software: A Step-by-Step Buyer’s Guide

Join Schlafender Hase on September 14th, as we guide you through the typical steps needed to properly identify the right tool for your organization and how to get it approved.

4 minutes read

A Guide to Medical Device Labeling Requirements

Navigating complex labeling requirements for medical devices. Your guide to the fundamentals of regulation and compliance and how automated proofreading can minimize your labeling risks.

5 minutes read

Preparing for a Paperless Future: How the Medical Device Sector is Embracing e-labelling

As the medical device sector continues to rapidly evolve, it is becoming increasingly important to ensure that patients and healthcare professionals have access to up-to-date product and safety information. E-labelling provides a convenient way to share important information. Here, Schlafender Hase’s Peter Muller explores the advantages of e-labelling for the medical device sector, as well as providing some practical tips for getting ahead with the processes, procedures and solutions necessary for a successful transition to e-labelling.

3 minutes read

Reducing Medical Device Packaging Waste and Improving Information Provision Through E-Labelling

E-labelling offers patients and healthcare professionals the convenience of always having up-to-date information on their products, such as the latest safety updates. It also provides regulators with greater oversight and assurance that manufacturers are providing accurate and timely information. Dr. Jutta M. Hohenhörst, from Schlafender Hase, explores the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies and add value for patients.

< 1 minute read

A Business Case for a Document Comparison Software: The Best Insurance Policy for Regulatory Affairs

Intensifying regulatory requirements leave no room for error when putting goods into patients and consumers’ hands. Yet in life sciences, one of the most strictly controlled industries, more than 50% of product recalls are caused by packaging errors