Michelle Lewis is a Senior Managing Consultant at Proxima CRO, a contract research organization that serves the emerging drug and medical device industries.
At Proxima, she will work on various medical device and drug product consulting projects across all stages of development. Proxima has worked with 20 companies on over 130 neuromodulation, neurology, and digital health and surgery-related projects across the regulatory, quality, and clinical spaces. These have included developing regulatory strategies, conducting literature searches, gap analyses, and regulatory submissions such as Informational Meetings, BDDs, Sprint Discussions, Pre-Submissions, Emergency Use Authorizations, Device Master Files, 510(k)s, and De Novos. We have provided clients with Quality Management System (QMS) support including SOP development, software documentation, QMS planning, QMS audits, gap analyses to various standards, and design file development and review. Due to Proxima's extensive experience with the FDA, we've developed a database of their responses culled from our large number of submissions. This information enables us to tailor every quality and regulatory project to FDA requirements and standards.
Prior to joining the Proxima team, Michelle served as the Director of Accreditation at the premier HCT/P standard setting body, non-profit, scientific, and educational organization, where she managed the accreditation program.
Michelle has created and managed complex quality and regulatory systems for a vast range of small, medium, and very large companies through her more than 25 years across the regulatory, quality, and clinical spaces in a medical device, drug, and biologic establishments. Michelle has also served in additional quality, regulatory affairs, and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications for 510(k), PMA, HDE, BLA, and IND products.
Michelle graduated from the University of North Dakota with a BA and a psychology major. She is also ASQ CMDA and RAC certified.
Michelle is passionate about engaging with startups and is eager to assist with the advancement of innovative technologies in health care.
University of North Dakota: Psychology, B.A.
American Society for Quality: Devices, biologics, drugs, CMDA
Regulatory Affairs Professional Society: US Devices, biologics, drugs, RAC
Proxima Clinical Research, Inc., Houston, Texas
Sr. Managing Consultant
Regulatory Affairs Manager
Periodic, Inc., Fernandina Beach, Florida
Principal Consultant
American Association of Tissue Banks, McLean, Virginia
Director of Accreditation
AlloSource, Centennial, Colorado
Senior QA Auditor - Analyst
Spectranetics Inc., Colorado Springs, Colorado
Senior Internal Auditor
Synthes, USA, Monument, Colorado
Regulatory Compliance Auditor
Baxter International Inc., Ames, Iowa
Center Manager
Baxter International Inc., Ames, Iowa
Quality Management Representative
Ms. Lewis has played an important role in the development of the following medical products:
De Novo Devices: AI/ML Aid in Prediction or Diagnosis of Sepsis Diagnosis
AI/ML & Software as a Medical Device (SaMD): SaMD AI/ML Cholianscopy, SaMD Radiology Scans (x2), SaMD Adjunctive Treatment for Major Depressive Disorder, Fetal AI/ML Ultrasound Aide, Radiological Acquisition and/or Optimization Guidance System
Devices with SaMD: Temporary Gastrointestinal Surgical Staple, Implantable Waveform Stimulator, Advanced Endoscopy for Cancer Diagnosis
Neurological & Neuromodulation Devices: Wearable Neuromodulation System, External Vagal Nerve Stimulator, Neuromodulation Pain Therapy Device, Brain-Computer Interface, VR Biofeedback
Cardiovascular & Circulatory Devices: Mechanical Circulatory Support Device, Implanted Mechanical Cardiac Circulatory Support and Renal Perfusion, Balloon Catheter, Catheter, Intravascular, Short-Term Less than 30 Days, Laser Ablation Catheter
Respiratory & Critical Care Devices: Mechanical Ventilation Device, Air Intake and Bacterial Filters and Accessories
Implantable Therapeutic Devices: Implantable treatment for Non-obstructive Underactive Bladder, Implantable treatment for Ulcerative Colitis, Implantable treatment for Colorectal Cancer, Implantable Expandable Stent for Pediatrics
Obstetric, Gynecological & Reproductive Devices: Home Uterine Activity Monitor, Assisted Reproduction Kit, Internal Therapeutic Massager for Treatment of Dyspareunia and Chronic Pelvic Pain, Menstrual Cup
Pediatric & Neonatal Devices: Wearable Neonatal Phototherapy, Implantable Expandable Stent for Pediatrics
Renal & Urological Devices: Extracorporeal Blood Purification, Peritoneal Dialysis Catheter, Neurogenic Bladder Management
Surgical & Endoscopic Devices: Endoscopy System, Instrument counters, Catheter Grip Tool, Power Tools for minimally invasive surgery, Excimer Laser System
Wound Care Products: Wound Dressing/Adhesive Bandage, Wound Closure, Wound Dressing/Adhesive Bandage with Antimicrobial Coating
Orthopedic Plates: Craniomaxillofacial Plates, Craniomaxillofacial Locking Plates, Locking Compression Plates, Curved Locking Compression Plates, Tibia Plates, Fibula Plates, Radius Plates, Ulna Plate, Olecranon Plates, Humerus plates, Femur Plates, Variable Angle Plates, Cervical Plates
Orthopedic Screws: Craniomaxillofacial Screws, Craniomaxillofacial Locking Screws, Cannulated Compression Headless Screws, Cannulated Locking Screws, Cannulated Conical Screws, Schanz Screws
Orthopedic Nails: Cannulated Nails, Cannulated Tibial Nails, Cannulated Tibial Nails with Bend, Intramedullary Nails, Femoral Nails
Orthopedic Systems & Tools: Lumbar Interbody Systems, External Fixators, Orthopaedic Cables, Craniomaxillofacial Fixation Systems, Craniomaxillofacial Distractor Systems, Craniomaxillofacial Surgical Case Systems, Craniomaxillofacial Surgery Tools and Accessories, Foot and Ankle Surgical Case and Tray Systems, Spine surgical Case and Tray Systems, Extremity Surgery Case and Tray Systems
Other Orthopedic Products: Bone Filler/Putty, Pain Relief Device
In Vitro Diagnostic (IVD) Devices: IVD Specimen Sample Containers, IVD PTSD diagnostic aid (x2), IVD PCR based testing platforms
Companion & Depression Diagnostics: Companion Diagnostic for Depression Clinical Trial Inclusion
Laboratory & Automation Devices: Laboratory Robot(s), Pill Crusher
Other Therapeutic Devices: Daily Activity Assist Device, Shortwave Diathermy
Combination Devices: Adhesive Hydrogel
Humanitarian Device Exemption (HDE): Lengthenable Telescoping Titanium Rods
Premarket Approval (PMA) Devices: Cervical Disc Replacement Implant (x2), Percutaneous Catheters for Cardiac Ablation, Lumbar Disc Replacement Implant (x2), Intradermal Filler
Veterinary Devices: Cortex Screws, Veterinary Cortex Screws Self-tapping, Veterinary Locking Screws, Veterinary Cancellous Bone Screws, Veterinary Compression Plates, Veterinary Kirschner Wires and Pins
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): HCT/Ps for transplantation, HCT/Ps for non-transplant use
Biologic Drugs: Dermal Filler, Plasma Protein therapies
Biologic License Applications (BLA): Adipose-Derived Mesenchymal Stromal Cells, Plasma Derivatives as Injectable Drugs
Wellness Products: Pain Relief, Anxiety relief
AATB, American Association of Tissue Banks
- Shipping and Packaging Validation Workgroup Member
- Auditor Course Development Author
- Standards Committee Member
- Accreditation Committee Member
