プロフィール詳細

プロジェクトを作成

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Anil C.に依頼

India

Over 25 years of experience as a Medical Device Regulatory Consultant | CDSCO | USFDA 510k | EU MDR CE Marking | SFDA |

プロフィール概要

Working towards catalyzing the Strategic Development of the Clients in the regulatory, quality assurance, manufacturing process development, product designs for the medical devices industries, Pharmaceuticals, R and D centers. The strategic development steps and stages include but not limited to the Turnkey projects for set ups, Equipment and utilities validations, Process validations, Obtaining the regulatory approvals like EU GMP, MHRA, USFDA, 510 (k), Establishment registration and Device Listing, CDSCO etc. Gap analysis, Registration of the products in countries, Obtaining the credentials like ISO 9001,ISO 13485 and obtaining CE. etc. are our activities. We provide Regulatory Consultant Service For ISO 9001, ISO 13485, CE Marking as per EU MDR, USFDA 510(k),21 CFR Part 820, FDA, GMP, ANVISA, TGA, and client audits towards GMP certification & product registration. We Have Successfully Handled 300+projects Related to Medical Device Manufacturing Industry and 100+ projects are the turnkey projects by including Layout Design, Clean Room Design, Facility Plant setup Design & Process validation. Efficient and effective relationship management With the client , communication skills with ability to lead & key influencers role in regulatory affairs, regulatory compliance systems, audits and quality assurance. Business Sector: Medical Device Manufacturing Industry; Primary packaging Manufacturing Industry; Drug Device Combination products Manufacturers; www.operonstrategist.com I can medical device companies for Device registration, quality management system compliance, Audit compliance, Development of products at each phases, Technical dossier compliance and review.

専門分野

• ☆ R
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices
• ☆ Medical Imaging/Radiology
• ☆ Interventional Radiology
• ☆ Dentistry
• ☆ Magnetic Resonance Imaging (MRI)
• ☆ Medical X-Ray
• ☆ Endoscopy
• ☆ Electrocardiogram (ECG)
• ☆ Diagnostic Radiology
• ☆ Medical Equipment & Supplies

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Technical Writing

Research Gap Analysis

Consulting Regulatory Consulting, Manufacturing Consulting

Product Development Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

CEO

Operon strategist

6月 2011 - 現在

学歴

M.Sc. Microbiology

Abasaheb Garware college, Pune, University of Pune

6月 1996 - 6月 1998

認定資格

• 認定資格の詳細は未入力です。