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MEDICAL DEVICES & DIAGNOSTICS

Medical Devices & Diagnostics Services

 

Technology Assessments

 

Business Development

 

Project Management

 

Licensing & Partnering Opportunities

 

R&D, Prototyping, Pilot Plants & EPC Sourcing

 

Supply Chain Recommendations

 

Operations Management

 

R&D, Engineering & Product Development Roadmaps

MEDICAL DEVICES & DIAGNOSTICS FOCUS

In Vitro Diagnostics

 

 

IVD Applications

 

  • Immuno

  • Molecular

  • Clinical Chemistry

  • Applied

  • Point of Care/Home

 

In each of the above application areas, our expertise spans the following topics:

 

  • Sample preparation

  • Assay kits and diagnostic platforms

  • Sensor surface chemistries and characterization

  • Signal detection systems

  • Informatics and regulatory compliance

 

You may also be interested in downloading the following supporting documents that highlight our IVD expertise:

 

Materials Development for Sensors & Devices

 

IVD

 

 

 

 

 

 

Medical Devices

 

 

Materials & Engineering

 

  • Biocompatibility analysis

  • Mechanical properties

  • Fabrication/scale-up

  • Sterilization

  • Surface chemistries & functionalization: Polymers, ceramics, glass, metals, alloys, composites, coatings of new emerging materials (including nanocoatings)

 

 

Application Areas

 

  • Stents

  • Pacemakers

  • Bone/Joint replacement

  • Heart Valves

  • Drug delivery systems

  • Implantable pulse generators

  • Defribillators

  • Catheters, Balloon

  • Dental

  • Anti-bacterial

  • Surgical tools

  • Monitoring devices (e.g. glucose)

  • Fluid Systems (e.g. Pumps, Valves)

  • ENT instruments

Regulations

 

 

Recommendations for product development and regulatory compliance:

 

  • Establishment registration (21CFR Part 807)

  • Medical device listing (21CFR Part 807)

  • Premarket notification 510(k) (21CFR Part 807 Subpart E)

  • Premarket approval, PMA (21CFR Part 814)

  • Investigational device exemption, IDE (21CFR Part 812)

  •  Quality system, QS/Good manufacturing practices, GMP (21CFR Part 820)

  • Labeling (21CFR Part 801)

  • Medical device reporting (21CFR Part 803)

  • Analysis of Databases: IVD products, 510(k),  PMA, CLIA, IVD OTC, IVD Recalls, medical device recalls

 

 

 

 

 

 

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