Anyone can claim experience - these 52 categories demonstrate Compliance Consultants' experience.
This is what we have been doing since 1987!!



Imaging Devices

X-ray Imaging Mammographic X-Ray Ultrasonic Imaging
PACS Viewer Thermographic Imaging Ultrasound Research
DICOM Electrical Impedance Tomography Patient Handling Beds/Chairs
CAT Scanner



Cardio Devices

ECG Monitor ECG Electrode TENS Central Station Monitoring System
Cardiographic Catheter Individual Use Electrocardiograph ECG Balloon Catheter Angioplasty
ECG Electrode Lead Wire Tele-Medicine Cardiovascular Restorative Rehabilitation Exercise



Instruments Diagnostic / Therapeutic Devices

Lasers YAG Blood Glucose Monitor Pulse Oximeter
LLLT Blood Pressure Monitor / Auscultatory Dental Class II
TENS Whole Blood, Differential Cell Counter Hearing
Powered Muscle Stimulator Medical Sterile Tubing Endoscopes
OBGYN Dosage Delivery System Isolation Bed
Laparoscope Sterilization In-Vitro Quantitative Qualitative Test



510(k) Services

513g Regulatory Investigation Humanitarian Device Exemption Medical Device Investments
EC mark Off Label Prescription Abbreviated New Drug Application
ISO 13485 Clinical Trial Design Medical Control Circuits
Electronic Health Records Bayesian Statistics Medical Device Design
Document Preparation Clinical Investigations Engineered Surfaces
Software Design



Recent compelling issues that confront medical device developers in submitting 510(k)s

Deciding When to Submit a 510(k) MDDS (Medical Device Data System) Active Patient Monitoring
FDA Guidance Documents Benefit vs risk evaluation where different Technological Characteristics Refuse to Accept
Appeal-Not-Substantially Equivalent (NSE) final decision