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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.
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