Techsol Hinge Clinica

Techsol specializes in offering value-focused medical device clinical research services powered with innovative GxP technology solutions to global sponsors who develop different classes of medical devices across therapeutic areas. Our MedTech team has extensive domain knowledge and practical experience in handling of end-to-end complex global trials and working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW for regulatory approval submissions.

With an unwavering focus on quality, patient safety and regulatory compliance, we have successfully delivered end-to-end Clinical Trial Services, Pharmacovigilance, Medical Device MDR Compliance and Regulatory Services to multi-national medical device organizations.

At Techsol, Quality Management and Compliance Oversight is an integral part of our all business operations right from the clinical trial design to final report generation. Our corporate quality team strives to ensure that are processes and technology platforms are aligned towards international standards and 100% compliant to global and local regulations.

We have the following Quality Certifications to Account for Our Process Excellence

ISO 9001:2015 Certificate Logo
ISO 13485 Certification Logo
ISO 14155 Certificate | Techsol

Services We Offer

Computer

How We Can Help

  • Preparation of Clinical Investigational Plans
  • Preparation of CER Writing for Class IIa, IIb,III devices
  • Preparation of PMCF (Post Marketing Clinical Follow up) Plans
  • Preparation PMCF Reports Class IIa, IIb,III devices
  • Protocol synopsis for pilot, pivotal, PMS, and RWE studies
  • Study reference manuals
  • Informed consent documents (ICD)
  • Patient information sheet (PIS)
  • Clinical Evaluation Report (CER) Writing
  • Performance Evaluation Reports (PER) for IVDs
  • Clinical Evaluation Reports (CER)
  • Patient Safety Narratives
  • Periodic Safety Update Reports (PSUR)
  • Medical Device Reporting (MDR) / Medical Device Vigilance (MDV)
  • Biocompatibility Evaluation Reports (BER)
  • Publications / Abstracts
  • Literature Search Reports

Compier - Literature Screening

Using our proprietary Compier Literature Screening platform, we can deliver regulatory compliant MedTech Writing Services with high quality and less turnaround time.

Medical Device Clinical Study

Using our proprietary Compier PMS platform, we can deliver regulatory compliant MedTech Data Services with high quality and less turnaround time. Our Compier solution enables to speed up various phases of the MedTech Clinical Investigations and support sponsors for conducting the following types of medical device clinical trials:

  • Feasibility Studies
  • Pilot Studies
  • Pivotal Studies
  • Post Marketing Studies
  • Observational Studies
  • Post Authorization Safety Studies (PASS)
  • Post-Marketing Clinical Follow-up Studies (PMCF) – Prospective and Retrospective
  • Investigator Survey Studies
  • Patient Survey Studies
Techsol Medical Device CE Marking Services

The CE marking is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in the EEA.

The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance and environmental requirements. The CE mark is required in all 27 member states of the EU, as well as Iceland, Norway, and Liechtenstein. Switzerland accepts the CE mark for some products and Turkey actually requires that many products be CE marked.

How We Can Help

  • 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
Medical Device Global Regulatory Agency Expertise | Techsol

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

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
Techsol EU MDR IVDR Support

EU MDR/IVDR Support

  • EU MDR 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

EU-MDR Remediation Support

  • Update clinical documentation from MED DEV Rev 4 to EU MDR
  • Prepare robust Gap analysis at a detailed level for better Remediation execution
  • Utilizing teams and maintaining confidentiality in Risk Management files, Restricted Materials documentation updates
  • Verifying the need for PMCF and if needed, develop practical PMCF plans/designs
  • Labeling remediation (IFUs, Content update, Artwork changes
  • Remediation of Tech files (update or rewrite) & Publish
  • Biocompatibility Assessments & Write BERs
Labeling Process

Medical Device – Labeling Implementation

  • Label creation and revision as per EU MDR, Global Harmonization Task Force (GHTF), and local requirements
  • Labelling Lifecycle and Change management
  • Labelling Compliance Assessment
  • Preparation and publishing of Electronic Instructions for Use (EIFU)
  • Label Translations

EU MDR – Labelling Revisions

  • 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

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
Techsol MetTech FSCA

How We Can Help

  • 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
  • Provide vigilance reports, along with any correspondence with Competent Authorities to as per ISO 13485 quality system standards
CDSCO Medical Device Techsol Services
  • Permission for import License/Product Registration
  • Wholesale License
  • Local agent services /Authorized Agent /Registration Holder
    Support
  • Manufacturing License
  • Loan Manufacturing Licence
  • Permission for test license to manufacture Medical Device
  • Permission to import/manufacture medical device which does not have a predicate device and IVDs
  • Permission for test license to import Medical Device
  • Permission to conduct Clinical Investigation for Investigational Medical Device
  • Permission to import/manufacture medical device which does not have a predicate device and IVDs
  • Regulatory consulting
  • Product Labeling services
  • Product launching strategies and consulting
  • Commercialization services
Technology Image

Our team has extensive knowledge to prepare and execute audits as per the requirements of ISO 13485:2016

  • Implementation of ISO 13485:2016 standards, conducting gap analysis and obtaining certification
  • 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

Scientific Technology Platforms & Managed Services

GxP Technology Platforms

We provide extensive technology consulting services and fully-managed platforms for Electronic Data Capture, Medical Coding, Clinical Trial Management, Drug Safety, pharmacovigilance and Post-marketing Surveillance to global sponsors as a standalone offering. All our solutions are validated to account for global regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, etc.)

Clinical Trial Discussion

Our MedTech expertise covers a wide range of medical device classes and study types, including but not limited to FIM studies, prospective CE Marking RCT (blinded / unblinded), and Post-Marketing Clinical Follow Up (PMCF) studies.

What We Think

Request for Services

Find out more about how we can help your organization by letting us know your areas of interest. We are always ready to have a conversation and begin a journey together.