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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
o Regulatory Strategies
o Regulatory Structure
• Government Liaisons 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, 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.
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