Industry-leading Expertise

Areas of Expertise

Medical Device Development

• Ideation 

• Discovery and intellectual property

• Feasibility, initial market research, and business planning

• Pre-development: Initial engineering design and prototyping

• Development: Engineering development phases, bench testing, pre-clinical, and pilot clinical work

• Manufacturing and Clinical development 

• Product approval

• Commercialization

Regulatory Classification

Development of the following classes of medical devices per FDA classification:

• Class I:  Low-risk, do not require a 510(k) clearance

• Class II:  Moderate-risk, require a 15(k) clearance

• Class III:  High-risk devices, requiring a Pre-Market Approval (PMA) for clearance

Compliance Requirements

• FDA and regulatory guidelines

• Device history file

• Good Laboratory practices (GLP)

• Good Clinical Practices (GCP)

• User needs, ergonomics, and human factors

• Design failure mode and effect analysis (DFMEA)

• Quality systems corrective and prevention action CAPA

Types of Medical Devices

• Wearable: Monitoring and diagnostics

• Implantable: Temporary and permanent

• Energy: Ablation 

• Catheters

• Sampling device tools

• Surgical tools

• Diagnostic devices

Procedural Approaches

• Surgical (open and laparoscopic)

• Interventional

• Robotic

• Endoscopy

Clinical Areas

• Cardiovascular

• Cardiothoracic (including surgery)

• Pulmonary and respiratory

• Gastrointestinal

Clinical Affairs

• Scientific Advisory Boards

• Clinical Consultants

• Clinical protocols and implementation

• Clinical sites and training

• Adverse Events Committee

• Clinical Monitoring Committee

• Clinical Research Organizations