We are leaders in designing and remediating quality management systems under strict and changing standards for medical device companies. MCRA ensures compliance with ISO 13485, FDA Quality System Regulation, and other global QMS requirements, with special emphasis in establishing procedures for regulatory compliance tailored to your product line and target markets.

Anesthesia and Critical Care Device Experience

MCRA offers unparalleled consulting support to develop quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements to support development of Anesthesia and Critical Care devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for Anesthesia and Critical Care devices all the way from device conception through release to market. Some key Anesthesia and Critical Care areas of expertise include:

  • Abnormal Breathing Sound Devices

  • Airway Monitoring Systems

  • Algesimeters

  • Anesthesia catheters, filters, and needles

  • Anesthesia gas and oxygen masks

  • Anesthesia gas machines and vaporizers

  • Anesthesia pain monitors

  • Apnea monitors

  • Breathing Frequency Monitor

  • Breathing Gases Mixer

  • Carbon dioxide absorber and anesthetic gas scavengers

  • CPAP and BiPAP devices

  • Cricothyrotomy devices

  • Dental Protectors

  • Depth of anesthesia monitors

  • Endotracheal, endobronchial, and tracheostomy tubes and stylets

  • End-tidal CO2 monitors and masks

  • Epidural catheters, needles, and delivery devices

  • Gas Analyzers

  • High flow oxygen delivery devices

  • Humidifier and masks

  • Hyperbaric chambers

  • Infant baby monitors

  • Laryngoscopes

  • Nebulizers

  • Nerve stimulators

  • Nitric oxide delivery and generating devices

  • Opioid use disorder devices

  • Oral and nasal airways

  • Oxygen concentrators

  • Oxygen conservers

  • Oxygen tents

  • Peripheral nerve blocks

  • Portable air compressor

  • Pulmonary function calculators

  • Pulse oximeters

  • Spirometers

  • Topical Anesthesia Applicator

  • Tracheobronchial suction catheters

  • Ultrasound guided nerve blocks

  • Ventilators

  • Ventilatory Effort Recorder

Quality Assurance and Manufacturing Services

Our team offers setup of procedures for document control, R&D, risk management, software development, supplier evaluation, and control of measurement equipment, amongst others.

Our comprehensive quality assurance and manufacturing consulting services include:

  • Quality System Development

  • Gap assessments

  • Manufacturing and materials

  • Mobile apps and software

  • Mock inspections

  • Perform internal quality system audits

  • QA support

  • Technical documentation and technical submissions

Contact an anesthesia and critical care Quality Assurance Expert

Services in Anesthesia and Critical Care Devices

Anesthesia Reimbursement

Anesthesia US Regulatory

Anesthesia CRO

Anesthesia Global Regulatory