Marion Wimberly's Contact Details

Marion Wimberly's Company Details

Operon Strategist|Medical Device Project Consultant|CE MarkConsultant | USFDA | FDA Consultant

Pimpri-Chinchwad, Maharashtra, India • 1 - 10 Employees
Hospital & Health Care

Operon Strategist is working towards catalyzing and ensuring the strategic development of the clients in the areas of Regulatory approvals , Quality Assurance, Quality Control, Licensing for the Medical Devices industry.We undertake turn key projects, annual regulatory contract as well as functions on the customized packages as per the need of the client.Medical Device Project consultancy services with 20+ years of experience in Handling regulatory projects Strong knowledge of Medical Device Regulatory and Primary packaging Regulations , Expertise in the Medical Device Layout design ,Clean Room Design and Process Validation , Medical Device Design And Development , Medical Device Regulatory Consultant, Medical Device Turnkey Project, clinical research and quality assurance.We Provide Turnkey Project and Regulatory Consultancy Services worldwide .We provide 50+services In Healthcare sector. We Have Successfully Handled 60+projects Related to Medical Device Manufacturing Industry and 30+ projects are the Turnkey projects By include Layout Design ,Clean Room Design , Facility Plant setup Design & Process validation.Regulatory experience in medical device Manufacturing industry /Primary Packaging Industry.We provide Regulatory Consultant Service For ISO 9001, ISO 13485, we have successfully handled Regulatory Project For CE Marking ,USFDA, USFDA 510(k),21 CFR Part 820 , FDA, GMP, ANVISA ,TGA ,and client audits towards GMP certification & product registration.Efficient and effective relationship management with client , communication skills with ability to lead & key influencers role in regulatory affairs, regulatory compliance systems, audits and quality assurance.Our Company Specialties: Regulatory Affairs, Regulatory Compliance, Audits & Compliance, Quality Assurance, Qualification/Validation ,Medical Device Design And Development.Handling Medical Device post Marketing support include clinical Evaluation ,CAPA management ,audit report and compliance.