DP offers a comprehensive set of services to assist clients in their pursuit of compliance and profitability. The medical device industry can be complex and confusing. So choose the experts that can lead you down the right path.
QUALITY SYSTEMS AND PROCEDURES
Quality system gap assessments
Corrective and Preventive Action (CAPA)
Compliance audits/due diligence
Unique Device Identification (UDI)/(GUDID)
NIOSH approval process for N95 respirators
Medical Device Single Audit Program (MDSAP)
FDA REGULATION AND SUPPORT
Write 510(k)s for medical devices
FDA audit support/remediation
FDA Quality System Inspection Techniques (QSIT)
FDA Medical Device Reporting (MDR)
FDA Investigational Device Exemption (IDE)
FDA Premarket Approval (PMA)
De Novo
Q Submission
Recalls
DESIGN CONTROL PROGRAM
Define and document design controls
Software validation
Life cycle assessment
Risk management
Supply chain
Nurse consultants
Technical writing
STERILIZATION EXPERTISE AND SERVICES
Ethylene Oxide (EtO) validations
Gamma & E-Beam protocol development
Aseptic processing implementation
Sterilization validation
Determination of best sterilization and packaging
INTERNATIONAL REGULATIONS
CE mark (IVDR, MDR)
EU authorized representative contact
Post market surveillance/vigilance
Technical file support
Clinical studies
BUSINESS SUPPORT
Logistics
Lean manufacturing
Six sigma
Facility design
IEC 60601
OSHA
Staff Training
DP will provide onsite or offsite training for the services referenced above.