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Delivering Patient-centric Medical Device Clinical Research Services 

Techsol provides best-in-class medical device clinical research, regulatory and pharmacovigilance services to global sponsors who specialize in developing different classes of medical devices. Our MedTech team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW for regulatory approval submissions.

We have strong domain capability to deliver Class I to Class III medical devices services in various therapeutic areas. Our team consists of experienced Medical experts, Biomedical engineers, Quality & Regulatory experts, labeling experts, Product engineers, CRAs, experienced Medical writers and Project Managers.

Meeting

Services We Offer

We offer the following services to sponsors for medical device clinical trials:

  • 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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Our team has extensive knowledge to prepare and execute 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
Technology Image

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 –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

EU MDR/IVDR Support

  • Due diligence
  • 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

Medical Device – Labeling Implementation

  • 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

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

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

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
  • PSUR writing
  • Provide vigilance reports, along with any correspondence with Competent Authorities to as per ISO 13485 quality system standards

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 (for IVDs),
  • CER (Clinical Evaluation Reports) for Medical Devices)
  • Medical Device PSUR Writing
  • Patient Safety Narratives
  • PDE /Toxicology reports writing

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.

Let Us Know How We Can Help You