Meeting regulatory requirements is an obligation that every medical device company must take seriously.
It is essential for companies to meet regulatory requirements for each country where they plan to sell their medical devices. Keeping up with the ever changing regulations and regulatory interpretations can be burdensome, especially to smaller startup organizations.
Our medical device industry expects are here to assist, and we provide the following services to support your regulatory needs.
Regulatory Strategy Recommendations
Determining the appropriate regulatory path for a medical device is complex and at times not straight forward. Several things must be taken into consideration including:
- Determining when to schedule a pre-submission meeting with the FDA
- Device indication for Use Determination
- Predicate device(s)
- Device Classification review for the applicable countries where the target market
- Device testing needs
(biocompatibility if applicable, electromagnetic testing, etc.).
- Usability studies
- Risk Management considerations
- Determining the type of submission needed / required:
– FDA 510K (traditional or abbreviated)
– De Novo submission
– PMA submission
Qualitas Compliance can assist in making recommendations on regulatory strategy, provide industry insights and recommend tools to make the regulatory process less stressful.
Predicate Device & Consensus Standards Review
Is your medical device in the development stage? We can assist in researching and reviewing potential predicate devices for your device intended use and help with identifying applicable standards that will be required for electro-magnetic compatibility, software validation, usability, biocompatibility etc.
“CE Marking” on a medical device means the manufacturer’s declaration that particular medical device complies with the general safety and performance requirements of the relevant European health, safety and environmental protection legislation.
Need assistance with developing Medical Device Files for CE marking? Contact Qualitas today to get started.
Unique Device Identification
FDA has established UDI requirements to track medical devices from manufacturing to end use. UDI can be complex depending on the classification of the device and determining how many layers of UDI labeling is required. Each manufacturer must be setup in the GUDID database to track and identify the following:
- Device identifier on the label
- Device name
- Company name
- MR safety status
- Premarket submission numbers
In addition to FDA, European Regulators have also issued guidances on UDI requirements and the EU MDR 2017/745 details UDI requirements for the EU markets.
Let Qualitas help you with understanding UDI and meeting UDI requirements.
Preparing for a FDA Inspection
FDA conducts inspections of medical device companies, are you prepared? If you need a quality compliance expert to review your quality management system or medical device for a “routine physical” in preparation for a potential FDA inspection we can help. Staying on top of documentation, quality initiatives and having a robust CAPA system is the best way to prepare for FDA.
FDA 483 Response
Has your company had a recent FDA inspection that resulted in a FDA 483 or quality deficiencies? Do you need assistance responding to the FDA? Qualitas can assist you in a timely response to FDA including: writing formal responses, evaluating root cause and setting up a corrective and preventive action plan to prevent future reoccurence.
Helpful Links: FDA and Medical Device Industry