Full Circle Consulting

EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.

Full Service

Full Circle Consulting

When

Product Development

Regulatory Submissions

Post Market Compliance

Manufacturing and Distribution

Why

Regulatory Strategy

Quality System Development

Quality System Implementation

EMMA OnDemand

Featured Services

COVID-19

EU MDR and IVDR

MDSAP

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Full Circle Consulting Resources

Regulating Electronic Nicotine Delivery Systems

Regulating Electronic Nicotine Delivery Systems

Studies are indicating the increasing use of electronic nicotine delivery systems (‘ENDS’) products, particularly amongst current smokers,[i] warranting an evaluation over the need for these products and if they have the potential to do less harm, if not no harm. Some in the public health community have advocated for the harm reduction approach emphasizing on the use of ENDS as an alternative combustible to tobacco products that may contain more harmful or potentially harmful constituents.[ii] Regulating and controlling tobacco use in the era of e-cigarettes has therefore not been an easy task.
Avoiding Statistical Biases in Clinical Trials

Avoiding Statistical Biases in Clinical Trials

Clinical trials, when conducted with great care, are the safest and fastest way in having a treatment approved for use to improve public health1. A clinical trial is an investigation conducted under a protocol which assesses the efficacy and safety of a treatment in humans.
EU MDR Delays

EU MDR Delays

It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.
EU MDR Common Specifications Are Not Common

EU MDR Common Specifications Are Not Common

A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).

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