Resources
Streamline Your Journey
Are you familiar with the regulations that apply to your specific product and business? RbM has made it our mission to simplify complex processes that streamline your journey from concept to reality. Our team has a deep working knowledge of and good relationships with numerous government and regulatory agencies to ensure you never miss a beat.
Concept To Reality
Support After Market
FDA
Device Advice is the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory education. It explains many aspects of medical device laws, regulations, guidance, and policies, encompassing the entire product life cycle.
RbM maintains a current registration with the FDA as a medical device contract manufacturer (Registration Number 2320968; Firm Establishment Identifier (FEI) 3003318268; Owner/Operator Number 9044762).
Any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.This means that even if a company only owns the device’s design and contracts the manufacturing to another company, they are still considered a medical device manufacturer and must register the business and list the device with the FDA:
Any work that the device design owner performs must be done in compliance with the FDA’s Quality System Regulation 21 CFR Part 820:
International Regulatory Agencies
Canada
The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs and medical devices offered for sale in Canada are safe, effective and of high quality.
RbM maintains certification to ISO 13485. By having this certification, the device design owner automatically has one of Health Canada’s submission requirements already addressed.
European Union
Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Regulations on Medical Devices include responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical devices.
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments.
RbM maintains certification to ISO 13485, which is an effective tool in the process for obtaining a CE mark since the regulation requires an appropriate quality management system. Like with Canada, by having this certification, the device design owner automatically has one of the requirements for CE marking already addressed.
Quality Management Systems
FDA
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.
As required by the FDA for any entity that designs or manufactures medical devices, RbM has established and maintains a quality system meets the requirements 21 CFR Part 820. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s).
ISO 13485
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g., technical support).
RbM maintains certification to ISO 13485.
ISO 9001
This International Standard specifies the requirements of a quality management system that can be used by an organization (performing any type of business) to improve its overall performance and provide a sound basis for sustainable development initiatives.
- The ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
- Facilitating opportunities to enhance customer satisfaction;
- Addressing risks and opportunities associated with its context and objectives;
- The ability to demonstrate conformity to specified quality management system requirements.
RbM maintains certification to ISO 9001. The potential benefits to an organization of implementing a quality management system are:
X-Ray Licensing
Many states require a license for the assembly, installation, and servicing of x-ray systems. Tennessee requires registering and tracking applicable x-ray producing equipment within Tennessee, and includes the review and registration of entities performing certain services such as the manufacture, distribution, servicing, and inspection of applicable x-ray producing equipment.
RbM is registered with the State of Tennessee to perform the services of assembly of radiation machines/x-ray equipment (License Number 41-35513-01E). We are registered in Tennessee as well as other states for the installation and servicing of radiation machines/x-ray equipment.
Radioactive Materials Licensing
Each state must have its own radioactive materials licensing regulations or adhere to the Nuclear Regulatory Commission’s regulations.
RbM has a radioactive material (RAM) license from the State of Tennessee that allows the use of radioactive material for research, development, testing, installation, preventive maintenance of specific medical devices at our facility (License Number R-01104). RbM also has a license from the Nuclear Regulatory Commission (NRC) for the distribution of exempt sources (License Number 41-35513-01E).
States without their own regulations are often referred to as Agreement States. Tennessee guidelines and NRC regulations are free to access:
Reciprocity
To work with radioactive materials outside of a company’s location state, the specific state radioactive materials license must include this scenario, and permission must be granted per date/activity by each individual state. This permission is called reciprocity.
RbM’s Tennessee RAM License allows radioactive material to be used for research, development, testing, installation, and preventive maintenance of specific medical devices at temporary job sites. Tennessee’s reciprocity requirements are also free to access.
ISO 13485
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g., technical support).
RbM maintains certification to ISO 134185, the international standard for quality management systems of medical devices, which is aligned with the medical device requirements of the EU.
With RbM’s ISO 134185 certification, the device specification/design owner has clear objective evidence/proof of that compliance for the activities RbM performs for their device, which supports the specification/design owner’s CE marking of their device.