U.S. Regulatory Compliance Services ... 

when timing, expertise and budgets matter


Spotlight Focus on FDA  ....

Summit on Healthcare Technology In

Nonclinical Settings

Both FDA and the Medical Device industry

recognize that a paradigm shift is underway in the

way and location where healthcare will be

administered for chronically ill patients and those

who do not suffer from conditions or illnesses that require intensive 'in-hospital' medical care.    The impact on how medical devices will be regulated is huge.   Going forward device manufacturers and Design Control 'core team' members (e.g., Regulatory Affairs, Engineers and Quality) must take into account more than ever 'human factors' considerations, enhanced risk management assessment techniques and more empirical evidence that Class II and III devices can be used safely in a home setting.   

The Joint AAMI/FDA meeting held in Octover 2014 highlights the key issues that must be considered in this new development environment.   Read the Report to learn more....

The FDA Safety & Innovation Act (FDASIA) mandates that FDAfurther medical device innovation. To this end FDA has released a draft guidance on the process for approving applications for clinical investigations of medical devices, and is also using its authority under FDASIA to review "direct" de novo device submissions.

RegulatoryPro provides an array of services to FDA, CMS and EPA-regulated companies, including chemical manufacturers, drug and biopharmaceutical companies and medical device firms

Bob Michalik, RegulatoryPro's founder and principal consultant (B.S., Biochemistry and J.D., Law)  has more than 25 years of experience in the chemical and pharmaceutical industries, including 15 years working in the area of regulatory affairs.   Bob provides direct'hands on'services to his clients which assures that a cost effective solution to product development and commercialization issues can be obtained on time and within budget.