HingeClinica is a world class partner for Medical Device services. We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and liaisoning.
| Medical Device Clinical Services: |
- Clinical Investigation Plans
- Feasibility Studies/Pilot studies
- Clinical Development for Pivotal Studies
- PASS (Post Authorization Safety Studies
- PMS Plans/PMCF Plans
- Post Marketing/Observations Studies
- PMCF (Post Marketing Clinical Follow up Studies)
- Biometrics Services (Clinical Data Management, Biostatistics & SAS Programming, Medical Writing)
- Literature search/reviews
- Publications
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| Audit and QMS Services (ISO 13485:2016) |
Carry out the audits as per the requirements of ISO 13485:2016
- Product & Process Risk Assessment
- Estimation & Control of Risk
- Premises Cleanliness requirements
- Personal Hygiene requirements
- Product Sterilization & Premises Fumigation requirements
- Product Installation & Servicing requirements
- Product Re-call procedures & Need of Improvements
- Technical Testing & Analysis of Medical Devices including Biocompatibility
- Evaluation of Design Parameters & Validation
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| Product Certification Support: CE Marking |
- Identification of EU MDR compliance requirements applicable to the Product
- Preparation of Product Technical File
- Provide guidance for Technical testing of Product as per Harmonized Standards.
- Identify the Conformity Assessment Process for CE marking of Product as per Risk Category of the Product – Guideline of MDR
- Risk Assessment of Product
- Submission of Technical Documents to Notified Bodies for CE Marking
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| Medical Device –Product Registration &Regulatory Submissions |
- Product Registrations
- US Regulatory submissions (510(k), PMA, 180 Day, 30 day Notices, RTR, IDE, Compassionate Use, HUD, HDE, CFG)
- International STED development
- Health Canada license amendments
- EU technical files, design dossiers, CE renewals and change notifications
- Clinical evaluation reports (CER)
- ROW market support
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| Post Market & Regulatory Services |
- FDA-483 and warning letter responses
- Consent decrees
- Recall support
- Support clients to develop remediation plans for Health Authority/ Notified bodies audits
- Liaison between company and regulatory agencies
- US agent services & establishment registrations
- Preparation of internal team for agency meetings
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| EU MDR/IVDR Support |
- Gap analysis of existing product dossier
- EU MDR/IVDR compliance strategy
- Changes in Notified Bodies
- Labelling review and updates
- Tech file remediation
- Design dossiers and renewals
- EUDAMED database management
- EU UDI implementation
- Regulatory strategy & Project deliverables US/EU/CA/ROW
- Marketing strategy support
- Due diligence
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| Medical Device – Labelling Label System Implementation |
Label Management
- Working on client’s network
- Label creation and revision
- Change management documentation
- Reports on all labeling related activities
- All data management handled off-site by Medical Device Labeling Professionals
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| Revising Labeling |
- Revisions to labels, cartons and IFUs
- Updates for MDR changes, notified body, numbers, EU authorization rep., etc.
- Creating space on cartons and labels for multiple languages
- Changes to Adobe Illustrator and In Design files
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| Rebranding |
- Graphics artists develop and implement new branding on all forms of packaging
- Update cartons, labels, and IFUs to meet current standards
- Revisions to graphics after mergers and acquisitions
- Management of artwork files
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| EU PMS – FSCA Reporting |
- Determine if a FSCA (Field Safety Corrective Action) and Field Safety Notice (FSN) are necessary and report to appropriate Competent Authorities.
- Complying FSCA reporting timelines as per MEDDEV 2.12/1 based on the severity of the incident.
- Inform your Notified Body of any incidents or FSCAs unless your device is Class 1 self-certified.
- Query responses to Competent Authorities regarding devices involved, and design changes
- Submit a Final Incident or FSCA Report to Competent Authorities.
- Medical Device Vigilance & Safety reporting
- PSUR writing
- Provide vigilance reports, along with any correspondence with Competent Authorities to as per ISO 13485 quality system standards
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