Why Choose ikenreg Consulting?
01. Team
We have a team of incredibly smart and impactful individuals having experience and expertise in regulatory affairs. We are flexible in nature, reliable, responsive, informed, prepared and innovative. Our team help you to solve pressing regulatory and quality challenges through onsite or remote consulting services. Our team is motivated by our client’s achievements.
02. Regulatory Affairs
We have a team of incredibly smart and impactful individuals having experience and expertise in regulatory affairs. We are flexible in nature, reliable, responsive, informed, prepared and innovative. Our team help you to solve pressing regulatory and quality challenges through onsite or remote consulting services. Our team is motivated by our client’s achievements.
03. Strategic Consulting
ikenreg will help you to navigate through the strategies and analysis of your business and aid in a remediation response plan. We also support you in expansion of strategies for new product development, end-of-life cycles, personnel assessments and staffing support.
04.Quality Assurance
Our team of leading quality assurance experts will work with you to ensure your business continuously improves and reaches its goals through increased quality and efficeincy. Our array of quality assurance solutions includes: Outsourced Quality Support, ISO 13485:2016, Medical Device Single Audit Program (MDSAP) and ISO 13485 Certificate Overview
05. Compliance Assurance
With increased scrutiny from the FDA and other regulatory agencies, companies in the medical devices industry are frequently implementing compliance assurance strategies. ikenreg will help you prepare for audits and assessments as well as develop a response to FDA findings to achieve the most effective compliance practices.