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.
Contact an ivd device Quality Assurance Expert
IVD 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 IVD devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for IVD devices all the way from device conception through release to market. Some key IVD areas of expertise include:
- Anemia in vitro diagnostics
- Antimicrobial resistance marker genetic in vitro diagnostics
- Antimicrobial susceptibility (AST) in vitro diagnostics
- Autoimmune disorder in vitro diagnostics
- Bacterial infection in vitro diagnostics
- Blood clotting disorder in vitro diagnostics
- Breath in vitro diagnostics
- Cancer in vitro diagnostics
- Cancer monitoring in vitro diagnostics
- Cancer Predisposition Risk Assessment in vitro diagnostics
- Cardiovascular disease in vitro diagnostics
- Chemistry analyte in vitro diagnostics
- Companion Diagnostic (CDx) in vitro diagnostics
- Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection in vitro diagnostics
- Diabetes in vitro diagnostics
- Digital Pathology in vitro diagnostics
- Drugs of abuse in vitro diagnostics
- Fever-causing infection in vitro diagnostics
- Food and other allergy in vitro diagnostics
- Fungal infection in vitro diagnostics
- Gastrointestinal bleeding in vitro diagnostics
- Gastrointestinal pathogens in vitro diagnostics
- Gene expression profiling in vitro diagnostics
- Gene expression profiling test system in vitro diagnostics
- Genetic health risk (GHR) in vitro diagnostics
- Heavy metal in vitro diagnostics
- Immune deficiency in vitro diagnostics
- Immunoglobulin light chain amyloidosis in vitro diagnostics
- Immunohistochemistry (IHC) in vitro diagnostics
- In vitro diagnostic instrumentation
- In vitro diagnostics supported by over the counter (OTC), point of care (POC), or CLIA waiver studies
- Infectious disease in vitro diagnostics
- Latent viral infection in vitro diagnostics
- Liquid biopsy in vitro diagnostics
- Medical Countermeasure in vitro diagnostics
- Minimal Residual Disease (MRD)/tumor burden in vitro diagnostics
- Neural tube defects in vitro diagnostics
- Next generation sequencing based tumor mutation profiling in vitro diagnostics
- Organ damage/disfunction in vitro diagnostics
- Pharmacogenetic/Pharmacogenomic in vitro diagnostics
- Postnatal chromosomal copy number variation detection in vitro diagnostics
- Primary hemostatic function in vitro diagnostics
- Respiratory pathogens in vitro diagnostics
- Semen analysis in vitro diagnostics
- Sepsis and septic shock prognosis in vitro diagnostics
- Sexually transmitted disease in vitro diagnostics
- Specimen collection devices
- Therapeutic Drug Monitoring (TDM) in vitro diagnostics
- Traumatic brain injury (TBI) in vitro diagnostics
- Viral infection in vitro diagnostics
- Women’s health in vitro diagnostics
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