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.
- Acquisition Integration
- Regulatory Compliance
- CERs and PERs
- EU MDR and IVDR technical Documentation
- FDA Regulatory Submissions - 510(k), De Novo
- AI/ML-Enabled Medical Devices and SaMD
- Worldwide Regulatory Strategy and Support
- Emergency Use Authorizations (EUA)
- Canada CTO (cells, tissue, organs)
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.
- FDA Quality Management System Regulations (QMSR)
- Internal and supplier auditing
- International standard for quality management systems (ISO 13485)
- Canada Medical Device Licence (CMDCAS)
- Mock EU MDR and IVDR audits
- FDA and MDSAP inspection readiness
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.
- Manufacturing Quality
- Manufacturing Site Transfer
- Quality Assurance Services
- Design Quality Engineering and Assurance
- Safety Risk management and field Action Management
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.
- Analysis of data and creation of PMSP: Post market surveillance Plans, PSUR: Periodic Safety Update Report, PMSR: Post market surveillance reports, CER: Clinical Evaluation Reports and PMCF: Post market Clinical Follow-up
- PMSP/PSUR/PMSR and CER orientation training courses and practical classroom instruction on preparation of PMSP/PSUR/PMSR and CER
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.
- Implement a team of creative strategic and tactical experts
- Remediation of DHF and technical documents
- Device reporting and complaints
- Warning letters, 483 findings, respond to FDA consent decrees and tactical execution
- Corrective actions for notified body non-conformity reports and execution
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.
- Deployed across all Enerxen Services
- PMP Certified Project Managers
- RA/QA Focused Professionals