Medical Devices

BCA has more than 15 years experience in medical device design. We are proficient in the application of the Medical Risk Management process as per ISO 14971 and IEC 60601-1.

Typically, our medical device design process includes a Device Hazards Analysis as part of the requirements phase. We review the Code of Federal Regulations, CFR Title 21, to determine the medical device class and pertinent performance standards. We design medical devices to conform to international standards as well as FDA and UL standards.

As part of the design phase, we perform a Failure Modes Effects and Criticality Analysis (FMECA), and stress, tolerance, and timing analyses to guarantee the safety of the patient and operators.

We also provide full technical documentation packages for 510(k) FDA submissions (e.g. Requirements Specifications, Design Documents, Verification and Validation Test Plans, Traceability Analysis, User Manual, Manufacturing Test Plan).

For more information on medical device design and regulatory compliance, see Regulatory Approvals, Medical Design.

Some examples of medical devices that we've designed are listed below.

• Infusion pumps (diabetes, patient-controlled analgesia)
• Ultrasonic surgery device (hemo-dialysis management system)
• Neo-natal endotrachial monitor
• Several ECGs (ambulatory, portable)
• Defibrillators and defibrillator trainers
• Power-assisted wheel chair
• Smart battery for a portable defibrillator
• Dental probe
• Hypothermia induction system