Below are some same sample questions often asked by visitors to our site, customers and/or businesses that currently manufacture / distribute medical devices on the US market, or plan to manufacture / distribute in the future.

​

Our consultants and/or customer service team can answer these questions and guide you throughout the stages of your business and device life cycle (from development through commercial release, post market, and end of life)

​

In what area(s) do we specialize?

As part of our custom services, QNR focusing on the following areas:

  - Meeting quality and regulatory requirements (for global agencies such as the US FDA);

  - Successfully launching medical device(s) on the US and other markets globally;

  - Supporting businesses and their devices throughout the lifecycle to maintain a continuous state of compliance.

​

Below is a sampling of some compliance activities and target markets where the QNR team can support your business:

​

Sample activities:

• Global strategy preparation, assessment, and execution;

• Collaboration with in-country affiliates for document preparation and submission;

• Working directly with in-country agencies and certification bodies for license and/or certificate approval.

• New product introductions, agency submissions, registrations and renewals in many markets globally.

​

Sample target markets (with activities):

• United States (FDA): 510(k) submissions, recall / field correction reporting, FDA inspection support, deficiency remediation and responses, Establishment registration and listing creation and renewal, Unique Device Identification (UDI) support;

• European Union (Notified Bodies, Competent Authorities): Significant and non-significant change notifications, dossier amendments, technical review support;

• Canada (Health Canada): Amendments (including fax back), annual renewals, MDSAP compliance and support, recall / field correction reporting, device license and importer support.

​

Other target markets:

• China (MNPA);

• South Korea (KFDA);

• Australia (TGA);

• Taiwan (TFDA, including QSD support);

• Brazil (ANVISA, INMETRO);

​

​

I'm looking to buy a medical product.  Can you help me?

QNR is a consultant firm that provides services in the areas of medical device support and business formation.  We do not sell and/or distribute medical products at this time.

​

I'm looking to speak with a medical professional for treatment.  Can you help me?

QNR is a consultant firm that provides services in the areas of medical device support and business formation.  We do not provide medical services and/or treatment for patients.

​

​

​

FAQ - Medical Devices 

Below are some sample questions often asked by business that our consultants can answer through QNR membership and/or a custom plan:

​

Medical device development:

Planning, assessment and strategy

  - How do I determine the regulatory pathway for my device?

  - What is the best approach for performing a regulatory assessment?

  - Is my product a medical device?  What is the classification of my device, and how is it determined?

  - What is an FDA product code, and how are FDA regulations applied to my device?

  - What is the typical “FDA info” requested by third parties for import/export, etc.?

  - How can I determine the acceptable indications for use and intended use for my device?  And what is the difference?

  - How can I determine if my device requires a 510k premarket submission to the FDA, or if it’s exempt?

  - How do I include / incorporate claims into my development strategy?  What claims can I make for my device?

  - How will I be able to advertise / promote my device, and what is an effective strategy for device claims, advertising and promotion? 

  - How do I determine what activity my company performs?  What are the requirements for companies that perform activities such as specification developers, legal manufacturers, contract manufacturer, distributor, and/or importer?

 

FDA Controls

  - What are the regulatory controls for my device?

  - What are general and special controls for my device?

• Class I (low to moderate risk): general controls

• Class II (moderate to high risk): general controls and Special Controls

• Class III (high risk): general controls and Premarket Approval (PMA)

​

FDA General Controls

  - What are adulterated and/or misbranded devices, and how can I prevent this from occurring?

  - What are the requirements for FDA establishment registration and listing?

  - What are an FDA Agent and FDA Official Correspondent, and what are the requirements?

  - What is the FDA FURLS database?

  - What qualifies as a device recall, and what are the required processes for device corrections / removals?

  - What is an adverse event report, a medical device report (MDR), and/or a Medwatch?  What are the requirements for medical device reporting?

  - What are requirements for device tracking, identification, and traceability?

  - What are requirements for unique device identification (UDI)?

  - What are the requirements for good manufacturing practices (GMP)?

  - What are the requirements for devices under special circumstances, such as custom devices, investigational devices, combination devices, enforcement discretion, denovo devices, and humanitarian devices?

 

FDA Special Controls

  - How can I determine what standards and guidance documents are applicable to my device?

  - How can I determine the specific performance standards for my device?

  - What are FDA consensus standards, and how are they applied to my device?

  - What are post market surveillance (PMS) activities, and how do I meet these requirements?

  - What are the requirements for labeling my device?

 

 

FDA Code of Federal Regulations (CFR):

Key FDA regulations related to medical devices

  - 21 CFR 801 – Device Labeling

  - 21 CFR 803 – Medical device reporting (Adverse events and reporting requirements)

  - 21 CFR 806 – Reports of corrections and removals

  - 21 CFR 807 – Establishment registration and device listing

  - 21 CFR 810 - Mandatory Device Recalls 

  - 21 CFR 812 – Investigational devices

  - 21 CFR 814 - Premarket Approval of Medical Devices

  - 21 CFR 820 – Quality Systems

  - 21 CFR 830 – Unique device identification (UDI)

 

Key FDA regulations related to medical devices (and other regulated products):

  - 21 CFR Subchapter A - General (1-99)

  - 21 CFR 7 - Voluntary Recalls

  - 21 CFR 50 - Protection of Human Subjects

  - 21 CFR 54 - Financial Disclosure by Clinical Investigators

  - 21 CFR 56 - Institutional Review Boards

  - 21 CFR 56 - Good Laboratory Practice for Nonclinical Laboratory Studies

  - Other applicable regulations

​

The FDA Quality System Regulation (QSR):

FDA Requirements for Quality systems

  - 21 CFR 820.20 Management responsibility.

  - 21 CFR 820.22 Quality audit.

  - 21 CFR 820.25 Personnel.

  - 21 CFR 820.30 Design controls.

  - 21 CFR 820.40 Document controls.

  - 21 CFR 820.50 Purchasing controls.

  - 21 CFR 820.60 Identification.

  - 21 CFR 820.65 Traceability.

  - 21 CFR 820.70 Production and process controls.

  - 21 CFR 820.72 Inspection, measuring, and test equipment.

  - 21 CFR 820.75 Process validation.

  - 21 CFR 820.80 Receiving, in-process, and finished device acceptance.

  - 21 CFR 820.86 Acceptance status.

  - 21 CFR 820.90 Nonconforming product.

  - 21 CFR 820.100 Corrective and preventive action.

  - 21 CFR 820.120 Device labeling.

  - 21 CFR 820.130 Device packaging.

  - 21 CFR 820.140 Handling.

  - 21 CFR 820.150 Storage.

  - 21 CFR 820.160 Distribution.

  - 21 CFR 820.170 Installation.

  - 21 CFR 820.180 General requirements.

  - 21 CFR 820.181 Device master record.

  - 21 CFR 820.184 Device history record.

  - 21 CFR 820.186 Quality system record.

  - 21 CFR 820.198 Complaint files.

  - 21 CFR 820.200 Servicing.

  - 21 CFR 820.250 Statistical techniques.

 

Agencies, Third Parties and Submissions

  - What are the agencies, government offices and other third parties involved with medical devices?

  - What are the requirements for an exempt device, and/or a pre-amendment device?

  - What are the requirements for a 510k submission?

  - What are the steps of the 510k submission process?

  - What are some best practices to ensure a successful submission and clearance?

  - What should I know about premarket approvals (PMA)?

 

Agencies, third parties and audits

What are the different types of audits?

What should I expect with an audit?

What are some tools and resources that auditors use when auditing?

What are some best practices for hosting a successful audit?

 

Auditing for compliance

  - What are some tools and resources typically used for auditing?

  - What are some best practices for auditing?

 

Careers in devices

  - What are best practices for becoming a quality / regulatory / medical device professional?