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What is a good consulting rate?
Tax consultants charge around $200 per hour. Web designers charge around $30 to $80 per hour, with $75 being the average. Alternately, they might charge a flat project rate of $500 to $5,000 per website. Management consultants charge between $100 to $350 per hour.
What is an FDA Class 2 medical device?
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43\% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.
What is a Class 2 medical device?
Who is on our medical device regulatory consulting team?
Our medical device regulatory consulting team is led by Laurie Clarke, JD, MPP, AB. Her knowledge and experience as a former FDA partner at top-ranked law firms enables her to effectively advise and advocate for clients throughout a device’s lifecycle.
What are the FDA classifications of medical devices?
FDA has classified all medical devices into either Class I, II, and III. Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the FDA. They can be found in 16 medical specialties or device panels. Here’s an example: Anything that begins with Part 870 is a cardiovascular device.
Should medical device companies hire Medical Device Consultants?
Medical device companies can benefit from consultants in many different ways. The right consultant can help create a strategy, implement quality management system (QMS) software, or navigate high-stakes situations such as device filings.
What are Class I and Class II medical devices?
Class I devices are the low-risk devices. There are about 780 of those. They require general controls, and I’ll talk about those general controls next. Class II devices require general controls and special controls. There are about 800 Class II medical devices.