Build SMART QMS

Help you Design, Implement and Manage the QMS fully customized through the extent of your Organization.

IMPROVE HEALTH OF YOUR IMPLEMENTED QMS

Services

MFG Facility
Design / Upgrade

Clinical Investigation
Clinical Performance Evaluation

QA / Regulatory
Document Design

Preparedness for
Certification

SMART Quality Management System

Intrust-Consulting helps its client to Develop an ISO 13485:2016 based SMART-QMS (Specific, Manageable, Actionable, Regulatory compliant & Total Quality Management System) which enables cross functional harmony & interdependence. The SMART-QMS helps our clients in maintaining consistent compliance and demonstration of QMS health during external audits and inspections. SMART-QMS improves itself as the need arises in a smooth way. The SMART-QMS shall comply with requirements of CDSCO-MDR 2017 & EN ISO 13485: 2016 for CE marking.

Design Verification & Validation

Our Core Values support your
Quality & Regulatory Aims

MDSAP QMS

Intrust-Consulting helps its client to achieve MDSAP-QMS (Medical Device Single Assessment Program Quality Management System) through design, implementation and monitoring. The MDSAP-QMS is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of Australia (TG-MD-R Sch 3), Brazil (RDC/ANVISA 16/2013), Canada, Japan (MHLW Ordinance 169) and the United States (21CFR820). The MDSAP-QMS compliance enhances product quality and acceptance worldwide and it helps manufacturer avoid regulatory country site inspections. They can submit the MDSAP-QMS certificates for easy access to registration of manufacturing site in these countries. As of now EU is not accepting MDSAP-QMS but its not far that the MDSAP will be admitted in EU registration process.

CDSCO MDR 2017

Intrust-Consulting advises manufacturers & importers to achieve compliance to CDSCO MDR 2017 (Chapters, Rules, Schedules, Forms & Amendments) requirements through a close interaction, hand-holding and training. Every thing that fits Medical Device Definition (GSR S.O. 648(E) 11th Feb-2020) will be under direct regulation from August 11th, 2023. Our SMART-QMS and Regulatory Technical Documentation Consultancy Services align perfectly well for achieving compliance and obtaining necessary licenses and trade documents. For this we take up green field and brown field projects in this segment.

Regulatory Technical Documentation (RTD)

Intrust-Consulting with its domain experience enables its clients to inculcate Technical Documentation right from Design Stage. The technical documentation includes information of product’s design, manufacturing process, supplier, safety & performance, product’s verification & validation information, labelling & packaging, Instruction for Use (IFU) and risk management report. In addition, one needs to write host of clinical work documentation. We enable through hand-holding and review. Our RTC services enables clients to achieve compliance for CE marking as per MDR-745 and IVDR-746. Our RTC enables for Post Market Surveillance (PMS), Periodic Safety Update Reports (PSUR), Summary of Safety and Clinical Performance (SSCP) and Post Market Clinical Follow Up (PMCF)

Medical Device & In Vitro Diagnostic Device Design Validation

Intrust-Consulting imparts training & help companies for Clinical Investigations of Medical Devices, Performance Evaluation & Clinical Performance Evaluations of In Vitro Diagnostic Devices. These can be aligned with ISO standards, global and local regulatory requirements. We interact with your Design Team to ensure complete compliance for design verification and validation. We have full experience in drafting EC protocols, Informed Consent Form, Investigator Brochures, Case Record Forms, Data analysis statistics and scientific writing for Technical Files, Peer Reviewed Journals and Blogs. Biocompatibility studies for biomaterials used in medical devices as per ISO 10993. Stability studies of Sterile Packaging, In Vitro Diagnostic Kits, IVD Raw Materials. Electrical and Electronic Safety.