About
Our expertise spans a diverse array of devices types, manufacturing processes, and therapeutic areas including software (SaMD), injection molding, CNC machining, sterilization, packaging, labeling, custom-made devices, dental, cardiology, neurology, sleep medicine, and artificial intelligence/machine learning-enabled devices (AI/ML), etc.
Drawing on a history of driving institutional success across different industries, we author comprehensive Regulatory Submissions such as 510(k)s, MDLs, and CE Marks, and provide ongoing support throughout the review process. We can assist you in establishing a QMS that meets the the requirements of the US FDA, ISO 13485, MDR 2017/745 etc.
Your organization works hard, so let RSE help you get credit for all that hard work during FDA Investigations and ISO audits by helping you automate quality records that will allow you to your business to shine during meetings with Regulatory Authorities.
From Distributor/Foreign Manufacturer Registrations to Customs/Import Compliance; we've got your back!
Most importantly, our compliance training programs can help your teams allocate necessary resources to catalyze improvements for the benefit of Patients and Caregivers.
In addition to keeping your Quality Management System healthy and compliant, we specialize in value- added quality process improvements that reduce costs and surpass efficiency milestones.
We accurately assess business needs, and rapidly develop actionable solutions to improve company function. Our consultants are affluent communicators with innate abilities to assess internal needs, have proven records of utilizing effective tools to capture untapped opportunities while mitigating risk, and possess strong business acumen with keen engineering aptitude to maximize operational effectiveness.
Madubuike Okafor
Principal Consultant
Madubuike Okafor, Principal Consultant at Regulatory Strategy Experts, Quality & Regulatory Consulting LLC is a seasoned professional leveraging over a decade’s worth of medical industry experience and relationships to provide consulting services for the benefit of patients and caregivers.
Madubuike's background includes:
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10+ years with a variety of medical device therapeutic areas spanning Class I and II in the US & CA and Class I and IIb in the EU.
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Experience with software (SaMD & SiMD), injection molding, CNC machining, 3D printing, sterilization, packaging, labeling, custom-made devices, dental, cardiology, neurology, artificial intelligence, sleep medicine, etc.
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Authoring several 510(k) clearances, and supported submissions for several CE marks and Canadian Medical Device Licenses along with the commercialization activities for all.
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Leading several FDA investigations; specializing in FDA 483 prevention via mock investigations.
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Leading & supporting several ISO 13485, and MDSAP audits for the maintenance of the certifications for multiple facilities.
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Experience with creating QMSes, implementing eQMSes & LMSes, and reconciling/merging/consolidating several QMSes after company mergers and acquisitions.
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International experience working with cross functional teams in countries such as France, China, and Japan for organizations spanning from start-ups all the way to larger corporations
Madubuike has a Bachelors of Science in Bioengineering from The Pennsylvania State University.
Regulatory Strategy Experts is a trusted resource for multiple medical device companies seeking guidance in navigating complex national and international regulatory landscapes.
