Medical Device Consulting Services
We help you develop and make compliant, market-ready medical devices at any phase.
Medical Device R&D | Project & Executive Management | Manufacturing & Operations | Quality Management | Regulatory| Clinical Support
Bringing your medical device to market, and keeping it there.
Our services are customized to your needs.
You are not locked into a rigid program.
Whether you are bringing a new medical device to the market or a small project navigating the design, operational, and regulatory environment, the objective is the same: Get your medical device to the market or your project completed. We know that this process can be challenging. We offer comprehensive services for complete projects or just a la carte according to your company or project needs.
Medical device technologies are evolving, and with that evolution comes increased challenges in all areas: R&D, manufacturing, preclinical studies, regulatory compliance,  quality management, and clinical studies. But you don’t have to navigate this challenging process alone.
That’s where M.L. Reo Consulting comes into the picture – we’re here to assist you with any questions or tasking in research & development, manufacturing, regulatory and clinical affairs, and quality management of your medical device. At any level of leadership or functional tasking, we can project manage parts of the project, the whole effort, or work as directed. We have a network of highly experienced (>15 years of experience) consultants to get the job done.
Leadership Team
Michael Reo
President
Andrew Shubel
Chief of operations
50+
YEARS OF EXPERIENCE
Our team has 50+ years of experience working with medical devices and has worked successfully with entrepreneurs, startups, and strategic companies.
Looking for customizable QMS or MDR documents or templates? Or a complete system?Â
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Medical Device Consulting Firm: Our Services
M. L. Reo Consulting is a medical device consulting firm specializing in all levels of project management, product research & development, manufacturing & operations, quality management systems, clinical support, and regulatory affairs. Whether you are an under-the-radar startup or an established device manufacturer, we can assist you from concept to commercialization.
- R&D
- Project Management
- CAD
- Prototyping & Fabrication
- Fixturing & Equipment
- Design Controls
- Risk Analysis
- Preclinical Work
Operations & Manufacturing
- Design Transfer
- Manufacturing Line Setup
- CNC Machining & Assembly
- Supplier Management
- Equipment Qualification
- Process Validation
- Distribution Contracts
- Packaging and Labeling
- Quality Management Systems (QMS)
- Remediation Services
- Risk Management
- Corrective and Preventive Actions (CAPA)
- GMP & ISO Pre-Audits
- Gap Analysis
- FDA & MDR Compliance
- Clinical Trial Setup & Support
- Regulatory Submissions
- Technical Files & Design Dossiers
- Clinical Evaluation Report (CER)
We have worked with M. L. Reo Consulting for a period of about 15 years. We have completed many successful projects together, in the fields of structural heart, ENT, neurovascular, and commercial products. I have found Mike Reo to be the most effective program manager I have worked with, as well as having great technical depth and creativity.
Jeff Christian
CEO @Phoenix DeVentures
Medical Device Consulting: Who We Serve
Our team of experts has experience and knowledge necessary to work with a wide range of companies around the world. Whether you are an established company, an under-the-radar startup, or somewhere in between, we have the expertise to advise you from concept to commercialization.
Established Organizations
Our medical device consulting services bring your operations to their full potential by streamlining processes that will contribute to your company’s future growth. Whether we are helping with product design, manufacturing, or advising on Quality System fixes, we give your business assurance that your risks are appropriately mitigated and your projects are moving forward at a startup pace.
Projects & Startups
By delivering world-class medical device consulting at each essential phase from product development to post-marketing requirements, we help startups overcome the challenges they face when navigating the medical device industry. M.L. Reo Consulting gives you the assurance that your product and business are performing at their best when you enter the market, and maintain that quality while in it.
Cardiovascular & Structural Heart
Orthopedic
Peripheral Vascular
Neurovascular
Renal
Ear, Nose, Throat (ENT)
Pulmonary
Sleep Apnea
M. L. Reo Consulting LLC