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The Schlafender Hase Team

SH Blogs
The Schlafender Hase Team

Med Tech in a Globalized World: Overcoming Regulatory Compliance Challenges for International Success

Despite stakeholders’ efforts to harmonize the medical device industry across regulatory jurisdictions, manufacturers face significant challenges in achieving global regulatory compliance. Gradually, however, we are seeing greater recognition globally of quality standards. In regions beyond Europe and North America, harmonization initiatives are well underway.

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The Future of Labels: Embracing Digital Technology for Enhanced Efficiency
SH Blogs
The Schlafender Hase Team

The Future of Labels: Embracing Digital Technology for Enhanced Efficiency

Think back to the early days of labeling – when medicines were sold by salespeople at events resembling circuses more than genuine health events. Consumers often had little to no knowledge of what was inside the medication bottle. In fact, the first US regulation on labeling, introduced in 1906, merely required that any listed contents were truthful.

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8 Trends Shaping the Future of Drug Labeling
SH Blogs
The Schlafender Hase Team

8 Trends Shaping the Future of Drug Labeling

Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs.

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Learning the New Language of the EMA and FDA: FHIR
SH Blogs
The Schlafender Hase Team

RAPS Webinar Highlights: Learning the New Language of the EMA & The FDA – FHIR

As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).

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Intro to TVT 12
SH Blogs
The Schlafender Hase Team

Introducing TVT 12: A New Era in Compliance and Efficiency

With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.

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