MED Institute
MED Institute offers comprehensive medical device product development services, from concept to testing. They specialize in regulatory compliance, risk analysis, and ensuring product safety and effectiveness for market launch.
MED Institute is a dedicated partner for accelerating medical product development, ensuring products are safe and effective for patients. With extensive experience, they guide projects through the entire medical device product lifecycle, from initial concept development and prototyping to rigorous testing and validation. Their expertise includes crucial areas such as acceptance criteria and boundary condition development, medical device risk analysis, and product development planning. MED Institute also excels in test method validation and development, alongside physiologic model development, ensuring a robust and compliant product. Services extend to comprehensive medical device testing, including durability/fatigue testing, failure analysis, radial force, electrochemical corrosion testing, particulate matter testing, and simulative use testing. They also provide physiological models & boundary conditions, ASTM F640-23 radiopacity testing, non-clinical in-vivo studies, and additional specialized testing. MED Institute is committed to delivering high-quality services that yield exceptional results and add significant value to their clients' businesses, as evidenced by their consistently high client satisfaction ratings.
About
**Who they are**
MED Institute is a medical device product development services provider that assists clients from concept through to market launch. They focus on regulatory compliance, risk analysis, and ensuring product safety and effectiveness.
**Expertise & scope**
* Comprehensive medical device product development services across the entire lifecycle.
* Regulatory insight and awareness of current industry requirements, including global bodies like FDA, NMPA, and PMDA.
* Engineering with clinical and regulatory insight to accelerate development and identify efficiencies.
* Risk assessment and analysis to ensure product safety and effectiveness.
* Development of acceptance criteria and boundary conditions.
* Test method validation and development.
* Physiologic model development.
* Support for regulatory submissions and responses to deficiency questions.
* Experience with design controls and validations.
* Post-market competitor evaluations.
**Reputation / proof points**
* Received client survey ratings of 4.99/5 based on 16 surveys since 2024.
* ISO 13485 certified.
* 16 years of ISO/IEC 17025:2017 accreditation.
MED Institute is a medical device product development services provider that assists clients from concept through to market launch. They focus on regulatory compliance, risk analysis, and ensuring product safety and effectiveness.
**Expertise & scope**
* Comprehensive medical device product development services across the entire lifecycle.
* Regulatory insight and awareness of current industry requirements, including global bodies like FDA, NMPA, and PMDA.
* Engineering with clinical and regulatory insight to accelerate development and identify efficiencies.
* Risk assessment and analysis to ensure product safety and effectiveness.
* Development of acceptance criteria and boundary conditions.
* Test method validation and development.
* Physiologic model development.
* Support for regulatory submissions and responses to deficiency questions.
* Experience with design controls and validations.
* Post-market competitor evaluations.
**Reputation / proof points**
* Received client survey ratings of 4.99/5 based on 16 surveys since 2024.
* ISO 13485 certified.
* 16 years of ISO/IEC 17025:2017 accreditation.
Additional information
MED Institute emphasizes the importance of upfront quality work to increase the likelihood of success in later stages of medical device development. Their reports are designed to help clients demonstrate how their devices meet quality and safety standards and are accepted by regulatory authorities globally. They collaborate with clients at any stage of the development process, from early feasibility R&D to formal verification and validation testing.
Key Highlights
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Offers comprehensive medical device development services from concept to commercialization.
Source
“We offer medical device development services at every stage of the product development lifecycle.”
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Possesses expertise in navigating global regulatory bodies including FDA, NMPA, and PMDA.
Source
“Navigating the medical device product lifecycle from concept to commercialization is an exciting journey. Working through global regulatory bodies (FDA, NMPA, PMDA) and their unique requirements is common practice for our engineering team.”
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Maintains ISO 13485 certification and 16 years of ISO/IEC 17025:2017 accreditation.
Source
“Our ISO 13485 certification and 16 year history of ISO/IEC 17025:2017 accreditation has given us assurance that our quality system is robust and our reporting is efficient.”
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Achieved client survey ratings of 4.99/5 based on 16 surveys since 2024.
Source
“For client surveys sent since 2024, we received ratings of 4.99/5 (16).”
Certifications & Trust Signals
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ISO 13485 certified.
Source
“Our ISO 13485 certification and 16 year history of ISO/IEC 17025:2017 accreditation has given us assurance that our quality system is robust and our reporting is efficient.”
-
16 years of ISO/IEC 17025:2017 accreditation.
Source
“Our ISO 13485 certification and 16 year history of ISO/IEC 17025:2017 accreditation has given us assurance that our quality system is robust and our reporting is efficient.”
Buyer Snapshot
Best for
- Medical device companies seeking end-to-end product development support.
- Providers needing assistance with regulatory compliance and risk analysis.
- Innovators looking to accelerate product concepts to market.
How engagement typically works
- Collaborative partnership throughout the product lifecycle.
- Tailored support based on client's current development stage.
Typical deliverables
- Medical device prototypes
- Risk analysis reports
- Test method validation documentation
- Regulatory submission support
- Physiologic models
Good to know
- Best when clients require deep regulatory and clinical insight integrated with engineering.
HQ:
West Lafayette, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Spain, India, Europe
Industries:
Medical Devices
Services Offered:
Risk analysis, Validation testing
Standards Supported:
IEC 62366-1, ISO 14971, Other
Has Participant Recruitment:
Yes
Is Accredited:
Yes
Nda Support:
Yes
Additional usability_human_factors_testing Details
Usability Study Types Offered
Both
Services Offered
Risk analysis, Product development planning, Test method validation and test method development, Acceptance criteria & boundary condition development, Medical device prototyping, Concept development, Physiologic model development
Standards Supported
ISO 10993-1, ISO 13485, ISO/IEC 17025, FDA, NMPA, PMDA, IEC 62366-1
User Types Supported
Both
Use Environments Supported
Both
Lead Time Band
Start in 0-2 weeks
Quote SLA
24-48 hours
Minimum Project Size
Custom
Pricing Model
Custom
