Regulatory Compliance – Enabling you to comply with the legal requirements of your marketplace.

Regulatory Compliance –
Opening the Door to the World

Regulatory Compliance can encompass a wide range of issues.  Depending on your type of product, there can be regulatory requirements on the specific product, your quality system, and your business.  These compliance needs can extend beyond the domestic arena into the international market. 

RbM’s processes in our quality system are established to support all of your product’s needs.  RbM can also help you implement any requirements for your business, should it be necessary.   We will look at your specific needs, tailor the right plan for you, and guide you and your product through implementation.

Let us help you get your product into the worldwide market!

EXAMPLES OF REGULATORY REQUIREMENTS
U.S.A
European Union
Product • Medical Device Premarket Notification (PMN) or Premarket Approval (PMA) + Nationally Recognized Test Lab (NRTL) Marking Technical File in compliance to EU’s MDD + CE Marking + Translation of Labeling to Native Language
• Non-Medical Nationally Recognized Test Lab (NRTL) Marking Appropriate EU Directive for product type
Quality System • Medical Device Quality system compliant to FDA’s 21 CFR Part 820 as applicable to the activities performed by you Quality system compliance to EU’s MDD as applicable to the activities performed at your facility
• Non-Medical Product Dependent Appropriate EU Directive for product type as applicable to the activities performed at your facility
Business • Medical Device Registered with the FDA for the appropriate activities the business performs. Lists the specific device. Facility has an Authorized Representative in the EU
• Non-Medical Product Dependent Product Dependent


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