Regulatory Submissions

International organization for Standards (ISO)

Need to find assistance with medical device consultants to write FDA, PMA, IDE, or 510k submissions? 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. We specialize in Medical Device projects such as:

Regulatory Consulting Services
  • Regulatory Strategies
  • Regulatory Structure
Government Liaisons and Meetings
  • US Food and Drug Administration (FDA) CDRH Advisory and Compliance Meetings
  • Health Canada Meetings
  • European Union EMEC Meetings
Medical Device Regulatory Submissions
  • US FDA Medical Device Premarket Approval (PMA) Applications
  • US FDA Medical Device Premarket Notification 510(k) Applications
  • US FDA Medical Device Investigational Device Exemptions (IDE)
  • European Union Common Technical Files (CTD)
  • European Union CE marking
  • Health Canada Canadian Medical Device Regulations (CMDR)
Quality Assurance and Compliance
  • Standard Operating Procedures(SOP) Development and Review
  • Quality Assurance Staffing and Management
Audits
  • QSIT / Good Manufacturing (GMP) Audits
  • ISO Audits
  • Good Laboratory Practices (GLP) Audits
  • CMDCAS Audits
Training
  • QSR Training
  • ISO Training
  • Good Laboratory Practices (GLP) Training
  • Good Manufacturing Practices (GMP) Training
  • Good Clinical Practices (GCP) Training
  • Validation Training
Medical Device Labeling and Promotional Materials Qualification and Validation
  • Process Validation
  • Cleaning Validation
  • Software Validation
  • 21 CFR Part 11 compliance
Clinical Consulting Services
  • Preclinical and Clinical Trial Design
  • Clinical Trial Monitoring
  • 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, artificial 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, angioplasty 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, and organization membership. With combined experience averaging 25 years in the medical and In-Vitro Diagnostic device field, Methodize Inc. has the ability to help your company reach its goals. Anyone can read the regulations, at Methodize Inc, we provide solutions that work.