You can review our offerings in the "Regulatory" and "Engineering" pages. Here we discuss our consulting plans.

Biotesting, device design/evaluation, the FDA approval process are grounded in science ... not guesswork! Failure to understand the underlying chemical, mechanical, biological and physiological systems leads to improperly designed tests, problematic device design and other nuisances, causing long and frustrating delays in the regulatory approval process. The result is costly product redesigns and, ultimately, costly delays in product release! 

Operating a high tech company brings with it a high level of on-going demands, and these demands can be overwhelming when the complex nature of device analysis and FDA submissions are factored in. Meeting the needs of the current medical device industry requires a comprehensive approach. Short-term consults often do not do justice to today's problems and are not cost effective for YOU - they pay us well, but cannot get the job done!

We prefer to quote on projects that give you the complete solution, and not the piece-meal approach favored by many consulting companies and device manufacturers alike. Focusing on the narrow view only results in more questions raised by the FDA and more and more time - and lost money - added to your valuable projects.

Contact us with your problem and we will quote you depending on your needs, the project scope and duration. We can even let you know if your problem is "local" and focused or must be solved in a broader context, such as the changing the current device material or revamping the design altogether! Problems seldom live in isolation and are often known by the "company they keep" (packaging flaws, manufacturing process flaws, end user difficulties, proper device biocompatibility and physical test design, bioburdens, sterilization incompatibilities, ......).

NOTE: Under no circumstances will we give you services you do not require or do not approve in advance!

We can provide your organization with short-term advisory projects, such as acting like a "sounding board" for your management and technical staffs, helping you properly launch a project.

Sometimes all your staff needs is an expert overview and opinion to place your project on the right track. In this case, the one-, two- or three-day consults may be the most effective. Though more costly per day than a Contract Package, the savings will be enormous when your staff knows the most efficient approach.

Our services may also be purchased on a retainer basis. Retainer services may include

• Answering questions by phone and/or fax 
• Performing testing at off-site and/or our laboratories
• Coming on-site for meetings and any necessary on-site development and research efforts
• Meeting with third party vendors and suppliers on the client's behalf
• Meetings with the FDA
• Acting as Expert Witness