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ISO 13485:2016 provides an international QMS standard and introduces notable changes, particularly in the area of risk management.
Europe's new IVDR 2017/746 will bring significant regulatory changes for IVD manufacturers selling in Europe.
Europe's new Medical Device Regulation 2017/745 (MDR) will bring substantial changes to the medical device industry. How will this affect your company?
Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.
This white paper provides an overview of new risk requirements and considerations for devices companies under the new standard.
Your conformity assessment route has implications for your business you might not expect. How do you know which route is best for you?
This white paper explores risk management procedures and protocols required to comply with ISO 14971.
Take a deep dive into the key elements of an EU Technical File, including preparation, formatting, and common elements.
In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.
This white paper discusses the European clinical investigation requirements and how to know when you're ready for this important step.
How do you classify a product that fits the definition of two or more product types? This paper explains borderline classification in the EU.
This white paper discusses PMCF study requirements in Europe and relevant changes under the new MDR.
This white paper discusses how to find a new European Notified Body for MDR compliance.
CE Marking is required to sell your medical device in Europe. Get an overview of the process, requirements, regulations, and more.
If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.
This white paper discusses key points of the Notified Body search, including how to find a new Notified Body well-suited to your company.
In this white paper, you will learn about the role of Eudamed under the new MDR and IVDR.
Vigilance reporting is confusing for many manufacturers in Europe but it is critical to comply with vigilance requirements. In this whitepaper, we'll answer your biggest questions about vigilance reporting.
Download this white paper for an in-depth look at conformity assessment options under the new MDR.
How to avoid errors in communication, planning, conduct, evaluation, or reporting of clinical studies that could delay your market access in Europe.
Learn about the standards, requirements, and benefits of medical device labeling and symbols. Includes a list of common symbols and meanings.
In this white paper, we discuss audit and assessment duties for Notified Bodies in Europe, including performing unannounced audits.
ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.
The clinical evaluation report (CER) is a key component of Technical File and the CE Marking process so it's important to get it right.
Regulatory expectations for risk management are increasing - what does this mean for medical device companies?