Physio-Logic
Regulatory consultancy focused on medical-device market entry, providing regulatory strategy, execution and clinical development support alongside quality assurance services. The firm emphasizes mapping regulatory pathways and managing execution through a scalable taskforce and multidisciplinary expertise to accelerate device approvals.
Industries
Nr. of Employees
small (1-50)
Physio-Logic
Products
InBody 570
The InBody 570 machine analyzes fat mass, body fat percentage, muscle mass, and fluid distribution throughout the body in just 45 seconds using Bioelectrical Impedance Analysis.
InBody 570 Body Composition Analysis
Body composition analyzer measuring fat, muscle, percent body fat, basal metabolic rate, and fluid distribution using patented technology.
BPC-157, Oral Application
A peptide therapy product used to promote tissue repair, enhance immune function, and support healing and recovery.
Comprehensive Digestive Stool Analysis 2.0 (CDSA 2.0)
Non-invasive stool test by Genova Diagnostics to identify and correct digestive issues.
Mediator Release Test (MRT®) Blood Panel Analysis
Blood test by Oxford Biomedical Technologies to detect food allergies beyond common allergens and guide inflammation elimination plans.
Bone Marrow Concentrate Stem Cell Therapy
A regenerative medicine procedure using bone marrow concentrate derived from the patient's own body to treat orthopedic injuries and arthritis by promoting natural healing and reducing pain.
InBody 570
The InBody 570 machine analyzes fat mass, body fat percentage, muscle mass, and fluid distribution throughout the body in just 45 seconds using Bioelectrical Impedance Analysis.
InBody 570 Body Composition Analysis
Body composition analyzer measuring fat, muscle, percent body fat, basal metabolic rate, and fluid distribution using patented technology.
BPC-157, Oral Application
A peptide therapy product used to promote tissue repair, enhance immune function, and support healing and recovery.
Comprehensive Digestive Stool Analysis 2.0 (CDSA 2.0)
Non-invasive stool test by Genova Diagnostics to identify and correct digestive issues.
Mediator Release Test (MRT®) Blood Panel Analysis
Blood test by Oxford Biomedical Technologies to detect food allergies beyond common allergens and guide inflammation elimination plans.
Bone Marrow Concentrate Stem Cell Therapy
A regenerative medicine procedure using bone marrow concentrate derived from the patient's own body to treat orthopedic injuries and arthritis by promoting natural healing and reducing pain.
Services
Develop regulatory roadmaps and market-entry strategies for medical-device products.
End-to-end management of regulatory submissions and coordination of activities to obtain approvals.
Support for clinical program planning and execution for medical devices in global markets.
Design and implementation of quality assurance processes and systems to ensure regulatory compliance.
Provision of lectures, workshops and summit participation on medical-device regulation.
Develop regulatory roadmaps and market-entry strategies for medical-device products.
End-to-end management of regulatory submissions and coordination of activities to obtain approvals.
Support for clinical program planning and execution for medical devices in global markets.
Design and implementation of quality assurance processes and systems to ensure regulatory compliance.
Provision of lectures, workshops and summit participation on medical-device regulation.
Expertise Areas
- Medical device regulatory strategy
- Regulatory submissions and approvals
- Quality management systems (QMS) for medical devices
- Clinical development for medical devices
Key Technologies
- Regulatory pathway mapping
- Regulatory submission dossier preparation
- Clinical study planning for devices
- Quality management systems implementation