Enerxen

Services

Consulting Services

Enerxen Consulting can effectively serve clients both onsite and remotely, allowing us to provide industry-leading solutions to medical device, IVDs and combination product companies in the following areas:

Regulatory Submissions and Services

Enerxen Consulting will provide you with a regulatory strategy that can succeed across the world. We are well versed in all clinical specialties and possess the expertise to ensure that your product gets to market and stays. We will make sure that your product(s) meet all regulations.

Quality Systems Development

Enerxen Consulting takes a balanced approach to streamline or develop a customized quality system. This ensures that you end up with the best quality management system imaginable to suit your unique needs. No short cuts taken here. We always rely on best practices and proven techniques to come up with the most workable solutions. Your success is our ultimate goal, and that can only be achieved when we implement a quality system that works best for you.

Quality Assurance

Enerxen Consulting will move heaven and earth to get your innovations to market. We use leading design quality and top of the line quality assurance methods and safety risk management. We will do everything possible to help you improve the lives of everyone who can benefit from using your device.

Post Market Surveillance

Ensuring that your device works safely and effectively from the start is of paramount concern, but it’s also critical that it perform well in the long term. Enerxen will use all our resources to carefully monitor and measure performance over time. Should we be alerted to any reduction in performance and/or malfunction, corrective actions will be immediately taken.

Remediation

Enerxen Consulting uses best practices when it comes to tactical and strategic approaches in addressing all challenges. We have the expertise to handle notified body non-conformity reports, FDA consent decrees, warning letters and 483 findings.

Project Management

Enerxen Consulting employs high ranking project managers, all PMP-certified with medical device expertise, whose focus is exclusively on RA/QA. Our highly qualified professionals exist across all Enerxen services and projects. All are accessible and are fully capable of ensuring that your projects move forward as quickly and efficiently as possible.