Criterion Edge
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Experienced in pharmaceutical, biologic and medical device regulatory writing, the Criterion Edge team of specialized medical writers provides our clients with the flexibility needed to meet your critical writing deliverables. In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.
Criterion Edge
2M ago
The pharmaceutical industry is an arena marked by constant evolution, particularly in the realm of regulatory requirements. This […]
The post Adapting to Regulatory Evolution- Pharma Writing Strategies for Changing Landscapes Introduction appeared first on Criterion Edge ..read more
Criterion Edge
3M ago
In the ever-evolving landscape of medical innovations, where the spotlight often dazzles with ground-breaking discoveries, and cutting-edge technologies, […]
The post The Art of Internal Documentation- Enhancing Efficiency and Compliance Across the Development Lifecycle appeared first on Criterion Edge ..read more
Criterion Edge
3M ago
In the ever-evolving landscape of the In Vitro Diagnostics (IVD) industry, one of the critical elements steering the […]
The post Decoding the Impact of Comprehensive Clinical Evaluation Reports in the IVD World- Navigating the Compliance Landscape appeared first on Criterion Edge ..read more
Criterion Edge
4M ago
In the swiftly changing realm of In Vitro Diagnostics (IVD), compliance is not merely a regulatory checkbox, it’s […]
The post Navigating the In Vitro Diagnostics Regulation (IVDR)- Your Comprehensive Guide to Compliance in an Evolving Landscape appeared first on Criterion Edge ..read more
Criterion Edge
4M ago
In the dynamic realm of pharmaceuticals and biologics, where innovation dances hand in hand with stringent regulatory requirements, […]
The post Elevating Pharma and Biologics: Strategies for Streamlined Documentation from Pre-Clinical to Submission appeared first on Criterion Edge ..read more
Criterion Edge
5M ago
The intersection of technology and healthcare has ushered in a new era of innovation, particularly with the integration […]
The post Navigating the Intersection of Technology and Healthcare: MDCG’s In-Depth Guidance on Medical Device Software and Hardware Integration appeared first on Criterion Edge ..read more
Criterion Edge
6M ago
The pharmaceutical and biopharmaceutical industries play a crucial role in healthcare, continually researching and developing new medications to […]
The post Navigating Bandwidth Challenges in Pharmaceutical Medical and Regulatory Writing appeared first on Criterion Edge ..read more
Criterion Edge
10M ago
Click here to watch the recording of this webinar. With the implementation of IVDR requirements, IVD manufacturers have […]
The post [FREE WEBINAR] It’s All Interconnected: Hidden Traps That Can Derail Your PER: Lessons Learned from the MDR-Compliant CER Writing Experience appeared first on Criterion Edge ..read more
Criterion Edge
10M ago
Click here to watch the recording of this webinar. The IVDR has many companies scrambling and feeling a […]
The post [FREE WEBINAR] IVDR Readiness: Creating a Blueprint to Build a Strong PER appeared first on Criterion Edge ..read more
Criterion Edge
1y ago
The Association for the Advancement of Medical Instrumentation (AAMI) has been hosting the AAMI/FDA/BSI International Conference on Medical […]
The post New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference appeared first on Criterion Edge ..read more