Dr. Mamta Gautam-Basak
24+ years at the U.S. FDA as an investigator and Lead Chemist for Quality Policy. PhD, IIT Delhi.
FDA strategy for medical devices
Medical devices, cleared with confidence
Former FDA device reviewers plan and manage your 510(k), De Novo or PMA, so regulatory gaps don't delay your launch.
- 510(k)
- De Novo
- PMA
- Q-Sub
- ISO 13485 QMS
Materials sciencePolymer segment, drag to rotate
The team
Former FDA device reviewers on your side
He evaluated premarket submissions and decided what was sufficient and what wasn't.
Tanmay is a polymer scientist and former lead reviewer at FDA's Center for Devices and Radiological Health (CDRH). He reviewed premarket device submissions, evaluated materials, biocompatibility and chemical characterization, and helped develop standards including ASTM F3718.
- Former CDRH lead reviewer
- Polymer scientist
- Biocompatibility & materials
- ASTM standards development
- i.He anticipates FDA's questions before they're asked, so you face fewer surprises.
- ii.He personally assesses materials, interprets test data and builds the scientific case.
- iii.Materials and biocompatibility, where FDA most often asks for more information, are his core specialty.
Anne Lucas
Retired FDA research chemist with 70+ publications. Reviewed IDEs, PMAs and 510(k)s for sterility, biocompatibility and toxicology, and helped shape ASTM and AAMI standards.
Dr. Abraham Joy
Chair of Bioengineering at Northeastern University and former NSF program director for Biomaterials.
Dr. Peter L. Goering
Toxicologist with nearly four decades at FDA's CDRH, most recently Deputy Director of the Division of Biology, Chemistry, and Materials Science.
The problem
Most device delays start long before FDA review
These are the gaps that most often stall a 510(k), De Novo or PMA.
- Choosing the wrong regulatory pathway
- Weak predicate selection
- Gaps in biocompatibility and performance testing
- Incomplete design controls and QMS records
How Tacticity helps
How we get your device to market
Get the strategy and science right
Confirm the right pathway, whether 510(k), De Novo or PMA, and plan your testing before you spend on it.
DeliverableRegulatory strategy report and timeline
Build a submission that holds up
We prepare or review your submission the way an FDA reviewer would, and find the gaps first.
DeliverableSubmission-ready package or reviewer-style gap report
Answer FDA and stay inspection-ready
Respond to FDA deficiency letters and prepare for inspections with a former FDA investigator.
DeliverableDeficiency responses and mock inspection report
How we work
From first call to FDA decision
- 01
Initial consultation
Tell us about your device and development stage. We flag the key risks and your likely pathway.
You receiveYour likely pathway and top priorities. - 02
Strategy and scope
We review your data, documentation and test plans, then set a strategy, timeline and fixed scope.
You receiveA device strategy with fixed deliverables and costs. - 03
Execution and FDA support
We prepare your submission, answer FDA's questions and get you inspection-ready, through to FDA's decision.
You receiveFormer FDA reviewers at every stage.
Why choose Tacticity
The difference former FDA experience makes
Former CDRH reviewers
We've judged device submissions from FDA's side of the table.
Materials science in-house
Biocompatibility, chemistry and toxicology experts on your team.
Standards insight
Advisors who helped shape the standards you test to.
FAQ
Common questions
Who do you work with?
Medical device companies in India and worldwide, from startups preparing a first 510(k) to established manufacturers answering FDA questions or preparing for inspections.
What happens during the initial consultation?
We discuss your device, stage and goals, then outline your likely pathway and key risks. You leave with clear next steps, whether or not you work with us.
What does your former FDA experience mean for us?
Our advisors have reviewed device submissions, conducted inspections and helped shape FDA standards. So we anticipate FDA's questions and build justifications that hold up.
Can you work with our existing regulatory or quality team?
Yes. Clients often bring us in for biocompatibility, chemical characterization or toxicology, or for an independent reviewer-style check of their submission.
Begin
Know what FDA is looking for, before you submit
Tell us about your device and development stage. We'll outline your likely pathway and the risks to address first.
Email
Office
Office 308, V18 Building, Balewadi High St, Baner, Pune, Maharashtra 411045
contact@tacticityadvisors.com