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Need to find assistance with medical device consultants to write FDA PMA, IDE, or 510k sumissions? Need to find medical device consultants to ensure compliance to the IVD Directive or FDA QSR?

Methodize Inc. can assist your in-vitro diagnostic and medical device company, manufacturer or distributor that specialize in In-Vitro Diagnostics and Medical Devices for all your Medical Device projects such as :

• Regulatory Consulting Services
  o Regulatory Strategies
  o Regulatory Structure
• Government Liasons and Meetings
  o US Food and Drug Administration (FDA) CDRH Advisory and Compliance Meetings
  o Health Canada Meetings
  o European Union EMEC Meetings
• Medical Device Regulatory Submissions
  o US FDA Medical Device Premarket Approval (PMA) Applications
  o US FDA Medical Device Premarket Notification 510(k) Applications
  o US FDA Medical Device Investigational Device Exemptions (IDE)
  o European Union Common Technical Files (CTD)
  o European Union CE marking
  o Health Canada Canadian Medical Device Regulations (CMDR)
• Quality Assurance and Compliance
  o Standard Operating Procedures(SOP) Development and Review
  o Quality Assurance Staffing and Management
• Audits
  o QSIT / Good Manufacturing (GMP) Audits
  o ISO Audits
  o Good Laboratory Practices (GLP) Audits
  o CMDCAS Audits
• Training
  o QSR Training
  o ISO Training
  o Good Laboratory Practices (GLP) Training
  o Good Manufacturing Practices (GMP) Training
  o Good Clinical Practices (GCP) Training
  o Validation Training
• Medical Device Labeling and Promotional Materials
• Qualification and Validation
  o Process Validation
  o Cleaning Validation
  o Software Validation
  o 21 CFR Part 11 compliance
• Clinical Consulting Services
  o Preclinical and Clinical Trial Design
  o Clinical Trial Monitoring
  o Evaluation of Clinical Data
• European Union Authorized Representative
• European Union In-Vitro Diagnostic (IVD) Directive 98/79/EC
• European Union Medical Device Directive 93/42/EC
  

Methodize Inc. can assist your medical device and in-vitro diagnostic company, manufacturer, distributor, for many different medical areas and products such as, pediatric medical devices, in-vitro diagnostic devices, sterile implantable medical devices, pacemakers, stents, artifical hearts, knee replacements, hip replacements, physical medicine devices, radiology devices, nuclear medicine devices, CAT scanning machines, PET scanning machines, disposable medical devices, contact lenses, hearing aids, cochlear implants, blood glucose meters, pregnancy test kits, latex gloves, breast implants, surgical gloves, condoms, intraocular lenses, IV, needles, blood bags, reproductive devices, nebulizers, mammography machines, single-use medical devices, electrical medical devices, biological medical devices, X-Ray , wireless medical telemetry,lasers, anesthesiology medical devices, surgical devices, sutures, angioplaty devices, apnea monitors, catheters, defibrillators, aneurysm clips, dressings, cardiovascular medical devices, ear, nose and throat medical devices, orthopedic medical devices, microbiology medical devices, opthalmic medical devices, pathology medical devices, toxicology medical devices, dental medical devices, immunology medical devices, neurology medical devices, surgery medical devices, plastic medical devices, medical gases, reusable medical devices, etc.

Need to find Medical Devices Consultants with specific requirements ? Methodize Inc’s convenient on-line form allows you to specify requirements for your Medical Devices and In-Vitro Diagnostics, consulting, auditing and training needs such as location, language, licenses, certifications, organization membership and experience with combined experience averaging 25 years in the medical and In-Vitro Diagnostic device field. Anyone can read the regulations, at Methodize Inc, we provide solutions that work.