Medical Devices and IVDs

Bring innovative medical device, IVD and combination products to market with our consulting and training services.

Establish, audit or remediate your quality systems with guidance from our team of former regulators. Our experts help you prepare for market, mitigate risk and achieve sustainable compliance with country-specific regulations and international standards.

How Can We Help?

Developing and Improving Quality Management Systems Establish, maintain or remediate your quality management system with the help of our expert consultants.

Getting Ready for Market Prepare for market launch by conducting clinical trials, developing regulatory filing strategies and ensuring inspection readiness.

Finding Solutions Respond to adverse regulatory inspection findings, build a compliant quality system and avoid future problems with a custom remediation plan.

Training and Education Bring about change that drives improvements.

Are You Ready for the In Vitro Diagnostic Medical Device Regulation (IVDR)?

Make sure your IVD complies with the IVDR requirements so it can remain on the market after the transition period ends on May 26, 2022.

Prepare with our free resources

Support During COVID-19

Our team is here to help you and the health care industry through these uncertain and fast-moving times.

Learn more about our services and support

Emergency Use Authorization Services

Our team can help you determine the appropriate pathway for your device and navigate the EUA process.

EUA Support Services for the Medical Device Industry

We Offer Custom Training

Training audience with woman raising hand

The Right Training for Your Team

Our interactive training courses are based on real-world scenarios and designed to help you meet international requirements, no matter where you are located.

Learn more about our training

Resources

Two of the Most Common IVDR Challenges (With Solutions)

Learn more about two of the most common challenges for IVD manufacturers in meeting IVDR compliance: performance evaluation and post-market requirements.

An Easier Approach to IVDR Technical Documentation

Before placing in vitro diagnostic (IVD) devices on the market, most manufacturers will need their technical documentation assessed by a notified body.

ISO 10993-23: The "Step-Wise" Approach to Evaluate Potential Irritants in Medical Devices Becomes Effective

Biological safety evaluation is an important piece of the puzzle to demonstrate the overall safety of a medical device. ISO 10993-23:2021 is a new standard that specifies procedures for assessing the irritation potential of medical devices, materials or their extracts.

News and Events

African Medicines Agency, Drug Shortages & More - January 2022 Pharma News

January 10, 2022

The January 2022 pharmaceutical news update looks at the creation of the African Medicines Agency, nitrosamine impurities, European drug shortage issues and more.

Top 10 FDA Inspection Findings & More, December 2021 Pharmaceutical News Update

December 9, 2021

Dr. Peter Gough looks at December 2021 news updates in the pharma sector, including the top 10 FDA inspection findings and more.

The State of Pharma Quality, GMP Certificates, November Pharma News Update

November 9, 2021

NSF International looks at the legislative and regulatory changes in the pharmaceutical sector in November 2021.

Meet NSF at Making Pharma 2021

August 31, 2021

NSF's health science experts will attend Making Pharma 2021, one of the UK’s largest pharmaceutical conferences and exhibition events.

See More News