Worldwide Medical Device / IVD / LDT Regulatory Strategy
As most medical product manufacturers know, navigating the regulatory and quality hurdles associated with legally marketing a new medical product in the United States can be daunting. Further navigating international regulations can be downright overwhelming. Van Hoven Consulting has extensive experience in US, Canadian, and EU (among others) regulatory and quality strategy and is available to help you today.
A comprehensive regulatory strategy includes:
Are you having trouble determining if your product is regulated as a medical device in the US or EU?
Do your competitors have 510(k) clearance for their product(s), but you don’t?
Are you being asked by buyers to provide evidence of domestic clearance?
Are you trying to gain a competitive advantage over your competitors by obtaining market clearance first?
Is it unclear to you the relationship between your marketing strategy and the content of your 510(k) submission?
The background Van Hoven Consulting offers includes researching and authoring strategy for over 50 different types of medical products of varying complexity, including mammographic X-ray systems, computed tomography x-ray systems, colonoscopes, percutaneous transluminal angioplasty catheters, laser ablation catheters, various surgical implants and surgical tools, dental implants, urological catheters and accessories, medical gloves, oximeters, hearing aids, numerous electrosurgical products, software products, ablation systems, and personal lubricants, among others. Utilize this breadth of experience today to know, once and for all, if and/or how your product is regulated.
If you’re unsure of the regulations, don’t tackle this important element of your business plan on your own. Van Hoven Consulting offers competitive pricing designed for the small business owner’s budget. Ask what I can do for you in 15 hours.
A comprehensive regulatory strategy includes:
- Determining if your product is a medical device
- Identifying the medical device class (US, Canadian, and EU) and / or classification (US only)
- Identifying the product code (US only)
- Identifying the predicate device(s)
- Identifying required testing, design, or manufacturing standards
- Determining appropriate product testing to be conducted and included with the submission
Are you having trouble determining if your product is regulated as a medical device in the US or EU?
Do your competitors have 510(k) clearance for their product(s), but you don’t?
Are you being asked by buyers to provide evidence of domestic clearance?
Are you trying to gain a competitive advantage over your competitors by obtaining market clearance first?
Is it unclear to you the relationship between your marketing strategy and the content of your 510(k) submission?
The background Van Hoven Consulting offers includes researching and authoring strategy for over 50 different types of medical products of varying complexity, including mammographic X-ray systems, computed tomography x-ray systems, colonoscopes, percutaneous transluminal angioplasty catheters, laser ablation catheters, various surgical implants and surgical tools, dental implants, urological catheters and accessories, medical gloves, oximeters, hearing aids, numerous electrosurgical products, software products, ablation systems, and personal lubricants, among others. Utilize this breadth of experience today to know, once and for all, if and/or how your product is regulated.
If you’re unsure of the regulations, don’t tackle this important element of your business plan on your own. Van Hoven Consulting offers competitive pricing designed for the small business owner’s budget. Ask what I can do for you in 15 hours.