Richard Janosko Consulting
Richard Janosko, RAC Medical Device Regulatory Affairs Consulting
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The Regulatory Affairs Professional functions as the interface between industry/academia/health care and local/state/federal/international regulatory agencies to assure compliance with the regulations and laws that apply to the development, approval, manufacture, quality, distribution, and marketing of regulated health care products.
24-hour, on-call, when needed, regulatory assistance
I am skilled in all aspects of medical device industry regulatory requirements. I specialize in United States Food and Drug Administration medical device regulatory issues for United States and international companies.
For start-up companies, I provide cost-effective assistance you need to comply with all the FDA Medical Device regulations and obtain FDA product approval. I guide you, and where necessary, assist you in establishing your company manufacturing and quality systems, and supply you with up-to-date operating procedures tailored to your needs that can be implemented and repeated by your staff. I keep you up-to-date on FDA regulation changes that may affect your company or products and provide concrete compliance recommendations.
Your ad hoc regulatory affairs department
When needed, you have 24-hour "on-call" general regulatory affairs advice and assistance.
The benefit to you lies in my ability to serve as your ad hoc regulatory department, providing the breadth and depth of expertise necessary to address the variety of regulatory issues and needs that you require. The advantages to you are that a Regulatory Affairs Certified specialist familiar with your needs is available only when needed.
For established companies, I provide that extra knowledge for specific projects when the experience isn't available in-house, or when your staff is stretched too thin to get things done to meet those aggressive schedules.
FDA 510(k) Premarket Notification Submission preparation
I work closely with your staff to prepare new product FDA Premarket Notification [510(k)] submissions. I then work closely with the FDA Center for Devices and Radiological Health, Office of Device Evaluation before and during the approval process to get that new product "cleared to market" in time for introduction at that next medical conference. I have had many successful submissions - many in record time.
FDA and ISO 9000 Standard Operating Procedures development and employee training
Complying with the good manufacturing practices requirements of the FDA Quality System Regulation and ISO 9000 Quality System requires up-to-date operating procedures and practices. I provide customized QSR/ISO 9000 compliance training for your staff and assist in establishing your company Engineering Design Controls, Documentation controls, Purchasing, Manufacturing, Quality and Regulatory Standard Operating Procedures. These FDA required procedures when properly developed and implemented will be fully compliant with requirements for ISO 9000 Certification and will assist in obtaining that CE mark for your new product.
FDA compliance support including FDA 483 and Warning Letter responses, recall assistance, and ongoing regulatory support such as regulatory research, regulatory strategy planning, and internal compliance audits
Once established, a functional quality system is dynamic. The company will have changes in personnel, growth, restructuring, new product introductions, and changes in manufacturing processes. These changes require periodic review of practices and procedures to assure continued regulatory compliance. I assist by performing FDA required internal quality system compliance audits and work with your staff to resolve inadequate audit findings.
As your ad hoc regulatory department I am "on-call" for all your ongoing regulatory support requirements such as hosting FDA inspections and assisting you in those critical times such as a product Recall or responding to a FDA regulatory action. When necessary I work closely with the FDA Office of Compliance as well as Regional and District FDA enforcement groups to help you comply with requirements and resolve FDA Warning Letter or FDA Form 483 observations.
Ongoing changes in the regulatory environment; new product development and product evolution require regulatory strategy planning and research. Frequently new product development requires research for potential regulatory impact, and or reviewing competitive products regulatory status.
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Please note: Since 2003 I have reduced my consulting practice to limited assistance to several select old clients.
I am not accepting new projects. Thank you.
Richard Janosko Consulting
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