Since its inception, EMMA International has been dedicated to providing consulting services to help ensure clients’ products advance seamlessly from concept to approval. Throughout this time, the company has continued to grow and expand, solidifying its position as a leader in the field. This growth and success are evident in EMMA International’s multiple recognitions on the Inc 5000 list, which highlights the fastest-growing private companies in the United States. The company’s unwavering commitment to delivering exceptional services and its ability to adapt to an ever-changing industry have been key to its continued growth and recognition.
EU
Record Control for a Regulated World
In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
EU MDR SSCP’s: The Importance of Readability
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.
HIPAA and GDPR’s impact on Medical Devices
The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.
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
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
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”).
Reporting Timelines for Adverse Events
When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse event...
EU Technical Files
A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the...
EU MDR: Importers
The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device the...
Choosing the Right Path for an FDA Submission
Choosing the correct pathway for submitting an application to get your product approved by the FDA can be...
Are Managers Equipped to Lead a Digital Transformation?
Are Managers Equipped – in terms of skills, competencies and courage to lead a digital transformation? ...
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