We work with the FDA to get your device on the market with ease.
AcKnowledge Regulatory Strategies specializes in Regulatory Affairs (RA) consulting exclusively for the medical device industry. When you hire us, you also hire our entire network of current and former FDA reviewers, scientists, engineers, and regulatory/quality experts. We understand that each medical device needs a specific and tailored strategy to earn regulatory clearance. We strive to work with the FDA to ease the review process and get your device on the market faster than our competitors.
Once you engage our services, we will set up a specific plan for your device or product so you have a clear understanding of what is necessary, when it’s needed, and why it’s required. Our goal is to ensure that you have well-defined expectations so we can work together to see your technology brought to market.
Here for the blog? Check out our latest posts!
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February 2019
- Feb 4, 2019 Med Device Monday: Hemospray from Cook Medical Feb 4, 2019
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January 2019
- Jan 11, 2019 FDA Friday - Srinidhi Nagaraja, PhD Jan 11, 2019
- Jan 7, 2019 Med Device Monday: The Fluobeam 800 and the PTeye System for Parathyroid Tissue Detection Jan 7, 2019
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December 2018
- Dec 3, 2018 Med Device Monday: Reclassification of the Female Condom Dec 3, 2018
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November 2018
- Nov 30, 2018 FDA Friday: Reclassification Nov 30, 2018
- Nov 12, 2018 Med Device Monday- BOSE’s Self-Fitting Hearing Aid Nov 12, 2018
- Nov 5, 2018 Med Device Monday: ThermoNeuroModulation Device to Treat Migraines Nov 5, 2018
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October 2018
- Oct 29, 2018 Med Device Monday: Aethlon's Hemopurifier Oct 29, 2018
- Oct 15, 2018 Med Device Monday: Breakthrough Device VectRx by NeoTherma Oncology Oct 15, 2018
- Oct 8, 2018 MDMonday: NERV Technology's Implantable Biosensors Oct 8, 2018
- Oct 1, 2018 Med Device Monday: Help for Dry Eyes by AesculaTech Oct 1, 2018
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September 2018
- Sep 17, 2018 Med Device Monday: BONEBRIDGE by Med-El Sep 17, 2018
- Sep 14, 2018 FDA Friday: Updates to our Previous De Novo Pathway Blog Sep 14, 2018
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August 2018
- Aug 27, 2018 Med Device Monday: Ellipsys Vascular Access System and the everlinQ endoAVF System Aug 27, 2018
- Aug 24, 2018 FDA Friday: FDA's Looking for Sites to Participate in their Experiential Learning Program Aug 24, 2018
- Aug 13, 2018 Med Device Monday: MolecuLight i:X Aug 13, 2018
- Aug 6, 2018 Med Device Monday: Zephyr Endobronchial Valve Approved by FDA Aug 6, 2018
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July 2018
- Jul 9, 2018 Medical Device Monday: Precision Flow HVNI Jul 9, 2018
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June 2018
- Jun 29, 2018 FDA Friday - Song P. Seto, PhD Jun 29, 2018
- Jun 25, 2018 MDMonday: MiniMed 670G Glucose Monitor and Insulin Pump for Pediatric Populations Jun 25, 2018
- Jun 15, 2018 FDA Friday: New Guidance for Humanitarian Use Devices Jun 15, 2018
- Jun 11, 2018 Medical Device Monday: Cala ONE's Essential Tremor Device Jun 11, 2018
- Jun 1, 2018 FDA Friday: FDA's New Challenge to Help Combat Opioid Use Disorder Jun 1, 2018
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May 2018
- May 14, 2018 Medical Device Monday: Gore Cardioform Septal Occluder Supplement May 14, 2018
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April 2018
- Apr 23, 2018 Medical Device Monday: Artificial Intelligence to Detect Vision Loss in Diabetic Adults Apr 23, 2018
- Apr 20, 2018 FDA Friday - Device Evaluation Intern Program Apr 20, 2018
- Apr 11, 2018 Wednesday Wisdom: Breakthrough Devices Program Apr 11, 2018
- Apr 2, 2018 Med Device Monday: Diagnostic for Detection of Brain Trauma Apr 2, 2018
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March 2018
- Mar 19, 2018 Med Device Monday: Guided CPR Device Mar 19, 2018
- Mar 5, 2018 Med Device Monday: Implantable Continuous Pump for Remodulin Mar 5, 2018
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February 2018
- Feb 26, 2018 Med Device Monday: Surgical Sealant Feb 26, 2018
- Feb 19, 2018 Med Device Monday: A Device to Treat Diabetic Foot Ulcers Feb 19, 2018
- Feb 2, 2018 FDA Friday - Samuel K. Shimp, PhD Feb 2, 2018
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January 2018
- Jan 19, 2018 FDA Friday - Cristin G. Welle, PhD Jan 19, 2018
- Jan 12, 2018 FDA Friday - Michael Nilo, MS Jan 12, 2018
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December 2017
- Dec 22, 2017 FDA Friday - Laura Gilmour, MS Dec 22, 2017
- Dec 15, 2017 FDA Friday - Nada Hanafi, MSc, MPH Dec 15, 2017
- Dec 8, 2017 FDA Friday - Caroline Rhim, Ph.D. Dec 8, 2017
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October 2017
- Oct 23, 2017 Med Device Monday: Nerve Stimulation for Sleep Apnea Oct 23, 2017
- Oct 16, 2017 Med Device Monday: Robotically-assisted Surgical Device for Adult Patients Oct 16, 2017
- Oct 9, 2017 National Cybersecurity Awareness Month Oct 9, 2017
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September 2017
- Sep 25, 2017 Med Device Monday: Safer C-sections Sep 25, 2017
- Sep 18, 2017 Med Device Monday: A Medical Device for Substance Use Disorders Sep 18, 2017
- Sep 11, 2017 Med Device Monday: Converting Anesthesia Waste into a Renewable Resource Sep 11, 2017
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August 2017
- Aug 28, 2017 Med Device Monday: Watching Patient Time Aug 28, 2017
- Aug 21, 2017 Med Device Monday: Easier Umbilical Venous Catheterization Aug 21, 2017
- Aug 14, 2017 Med Device Monday: Wearable Photobiomodulation Devices Aug 14, 2017
- Aug 7, 2017 Med Device Monday: Artificial Womb Aug 7, 2017
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July 2017
- Jul 31, 2017 Med Device Monday: Nonabsorbent Dressing Jul 31, 2017
- Jul 24, 2017 Med Device Monday: The First Neonatal MRI Jul 24, 2017
- Jul 17, 2017 Med Device Monday: Class II Device Types Exempt from Premarket Notification Jul 17, 2017
- Jul 10, 2017 Med Device Monday: Cool Ones! Jul 10, 2017
- Jul 3, 2017 Medical Device Monday: Tongue Depressors Jul 3, 2017
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June 2017
- Jun 26, 2017 Med Device Monday: Dentures! Jun 26, 2017
- Jun 12, 2017 Med Device Monday: Sentinel Cerebral Protection System Jun 12, 2017
- Jun 5, 2017 Med Device Monday: Ingestible Event Marker Jun 5, 2017
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May 2017
- May 30, 2017 Med Device Monday: Bone Mills May 30, 2017
- May 22, 2017 Med Device Monday: Flourish Esophageal Atresia and Humanitarian Devices May 22, 2017
- May 16, 2017 What's Changed with FDA User Fees? May 16, 2017
- May 8, 2017 Med Device Monday: Quicker Diagnosis for Concussion May 8, 2017
- May 1, 2017 Med Device Monday: Treatment for Cluster Headache Pain May 1, 2017
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April 2017
- Apr 24, 2017 Med Device Monday: Memory Impairment Test Apr 24, 2017
- Apr 17, 2017 Med Device Monday: Class I Device Types Exempt from Premarket Notification Apr 17, 2017
- Apr 10, 2017 Med Device Monday: Raindrop Vision Inlay Apr 10, 2017
- Apr 3, 2017 Med Device Monday: Ablation Catheter Apr 3, 2017
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March 2017
- Mar 27, 2017 Med Device Monday: C-Section Retractor Mar 27, 2017
- Mar 19, 2017 AcKnowledge Is Growing! Mar 19, 2017
- Mar 13, 2017 Med Device Monday: Medical Device Cybersecurity Mar 13, 2017
- Mar 6, 2017 Med Device Monday: Lumendi Mar 6, 2017
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February 2017
- Feb 27, 2017 Med Device Monday: SEEKER System from Baebies Feb 27, 2017
- Feb 20, 2017 Med Device Monday: Triggerfish Feb 20, 2017
- Feb 6, 2017 Med Device Monday: The Future of 3D Printing Feb 6, 2017
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January 2017
- Jan 30, 2017 Med Device Monday: Breast Tissue Expander Jan 30, 2017
- Jan 23, 2017 Med Device Monday: Restless Leg Relaxer Jan 23, 2017
- Jan 16, 2017 Med Device Monday: BrainPulse 1100 Jan 16, 2017
- Jan 10, 2017 Med Device Monday: Bone Anchors Jan 10, 2017
- Jan 2, 2017 Med Device Monday: Surgical Smoke Clearing Jan 2, 2017
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December 2016
- Dec 26, 2016 Med Device Monday: FDA's Rare Ban on Powdered Gloves Dec 26, 2016
- Dec 19, 2016 Med Device Monday: Preventing Recurring Strokes Dec 19, 2016
- Dec 12, 2016 Med Device Monday: Needle-Free Shots Dec 12, 2016
- Dec 8, 2016 Top Ten Gift Ideas for the Regulatory Affairs Professional Dec 8, 2016
- Dec 5, 2016 Med Device Monday: LASIK Study Dec 5, 2016
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November 2016
- Nov 28, 2016 Med Device Monday: Obalon Weight-Loss Balloon System Nov 28, 2016
- Nov 21, 2016 Med Device Monday: Expanded Use for a Heart Valve Nov 21, 2016
- Nov 7, 2016 Med Device Monday: Bacterial Vaginosis Detection Nov 7, 2016
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October 2016
- Oct 31, 2016 Med Device Monday: Companion Diagnostics Oct 31, 2016
- Oct 24, 2016 Med Device Monday: Mammography Oct 24, 2016
- Oct 17, 2016 Med Device Monday: A Symphony Oct 17, 2016
- Oct 10, 2016 Med Device Monday: Artificial Pancreas Oct 10, 2016
- Oct 3, 2016 Med Device Monday: Briteseed and SafeSnips Oct 3, 2016
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September 2016
- Sep 26, 2016 Med Device Monday: Blümio Sep 26, 2016
- Sep 19, 2016 Med Device Monday: Bloom Inhaler Sep 19, 2016
- Sep 12, 2016 Med Device Monday: Allotrope Ureter Detection Sep 12, 2016
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August 2016
- Aug 29, 2016 Med Device Monday: 3D Printed Tracheal Splint Aug 29, 2016
- Aug 22, 2016 Med Device Monday: Not Your Average Cast Aug 22, 2016
- Aug 15, 2016 Med Device Monday: Prosthetic Face Aug 15, 2016
- Aug 8, 2016 Med Device Monday: Chin Implants Aug 8, 2016
- Aug 1, 2016 Med Device Monday: REBIScan Aug 1, 2016
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July 2016
- Jul 25, 2016 Med Device Monday: MelaFind Jul 25, 2016
- Jul 22, 2016 FDA Tips, Tricks, and Trends Jul 22, 2016
- Jul 18, 2016 Med Device Monday: Medical Maggots Jul 18, 2016
- Jul 11, 2016 Med Device Monday: Cerêve Insomnia Aid Jul 11, 2016
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June 2016
- Jun 27, 2016 Med Device Monday: Lifestand Upright Wheelchair Jun 27, 2016
- Jun 20, 2016 Med Device Monday: Ostom-i Alert Jun 20, 2016
- Jun 13, 2016 Med Device Monday: ReWalk Exoskeleton Jun 13, 2016
- Jun 10, 2016 The de novo Pathway: Is It Right for My Device? Jun 10, 2016
- Jun 6, 2016 Med Device Monday: Owlet Baby Vitals Monitor Jun 6, 2016
- Jun 3, 2016 Wellness Devices vs. Medical Devices Jun 3, 2016
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May 2016
- May 30, 2016 Med Device Monday: Cochlear Implants May 30, 2016
- May 23, 2016 Med Device Monday: eSight May 23, 2016
- May 16, 2016 Med Device Monday: Brainport V100 May 16, 2016
- May 13, 2016 How I Broke into Regulatory Affairs, and How You Can, too. May 13, 2016
- May 9, 2016 Med Device Monday: Limbitless May 9, 2016
- May 6, 2016 Why I Do What I Do May 6, 2016
Banner photo of view from FDA Building 66 - CDRH by Alain Jaramillo
Snapshots by Nicholas Andrews and Phalinn Ooi