Consulting Services
Our services span a broad spectrum.
What we do
Expert Consultation on Medical Device Directives and MDR Regulations.
We are committed to providing access to affordable and innovative research solutions.
Our products and consulting services are spread across our core businesses of medical device industry includes System
Engineering, Regulatory Compliance, Design Quality Engineering, Validation and Verification, Reliability, Biocompatibility,
Material science, Toxicology, Chemistry Solutions, Vendor search, and Cost reduction processes around the world.
We work providing solution full or part wise depending on customer needs.
We do background research and provide an accurate and unique solution to every problem.
We are investing in businesses of the future digital healthcare, biological safety of medical devices, Advance analytical solutions, advanced robotics, AI, data science etc.
Evaluating large and diverse portfolios
Therapeutic Devices (Dialysis machines)
Diagnostic Devices (Ultrasounds, MRI, CT scanner)
Surgical Devices (Robotics surgical system)
Life Support Devices (Ventilators, Sleep devices)
Implantable Devices (Orthopedic, Dental)
Single-Use Devices (Catheters)
Consultation on New Medical Device Product Development
Our expert consultation services for new medical device development guide you through every step, from concept to market.
We help navigate regulatory requirements, ensure compliance, and optimize design for safety and efficacy. Partner with us to
bring your innovative medical device ideas to life with confidence and precision.
MSDS, TDS, and Declaration certificates preparation for chemicals
We assist the chemical, plastic, textile, metal, paint, adhesives, and ceramic industries with preparing Material Safety Data Sheets
(MSDS), Technical Data Sheets (TDS), MDR-compliant declarations, and toxicological risk assessments for chemicals used in
the production of medical devices.
Comprehensive Literature Review
We conduct literature reviews using the methodology outlined in Annex C of ISO 10993-1.
Biocompatibility
Consultation on the Writing, Review, and Assessment of the following, among other areas:
* Biological Evaluation Plans (BEPs)
* Biological Evaluation Reports (BERs)
* Biocompatibility Summary and Risk Assessment Report
* Chemical Characterization Report interpretation
* ISO10993 standard Gap Assessments
* Complaint data analysis and reporting
Material Science
Assisting with Material Selection, Preparation, and Review of Material Evaluation Summaries in relation to the following points:
* Regulatory and Compliance Considerations
* Mechanical Properties
* Chemical Characterization
* Material Testing guidance
* Supplier Evaluation and Management
* Failure Analysis and Troubleshooting
* Lifecycle Management
Toxicological Risk Assesment
Consultation on the Writing, Review, and Assessment of Toxicological Risk Assessment of Medical Devices
* Toxicological Risk assessment per ISO 10993- 17:2023
* Comprehensive toxicology
* Hazard, and risk assessment
* Scientific and medical writing services
* Establishing health-based exposure limits
Regulatory Compliance
Consultation on Regulatory Compliance
* General Safety and Performance Requirements (GSPR)
* Clinical Evaluation and Investigation
* Technical Documentation
* Quality Management System (QMS)
* Post-Market Surveillance (PMS)
* Vigilance Reporting
* Unique Device Identification (UDI)
* Notified Body Involvement
* Labeling and Instructions for Use
DHF Remediation
Consultation DHF Remediation
* Gap Assessment
* Technical Documentation Update
* Risk Management File
* Usability Engineering File
* Biological Evaluation
* Design Verification and Validation
* Labeling and IFU
* Clinical Evaluation
* Post-Market Surveillance (PMS)
* Notified Body Interaction
For Medical Device industry suupliers
* MSDS preparation
* MSDS update
* TDS preparation
* Declaration writing on ROHS, RSL, SVHC, CMR, ED, Nanomaterial, Substance of Animal, Plant and Human origin.
* High Risk Material Evaluations