Regulatory, Clinical & Quality Affairs for the MedTech Industry

©2019  H.M.Da Consulting & Development Ltd.

Follow us on 

V&V guidance, Due diligence, Usability, UDI, PMS and many more

The design and preparation of appropriate verification and validation testing protocols and the summary of the results of these tests in effective reports are time intensive tasks and should always start with a validation master plan. The amount and extensiveness of testing needed is based on your product’s risk profile. If you do not have dedicated personnel on your staff, don’t let this be a barrier to performing these necessary tasks.

 

The experienced team at HaMaDa can assist your company by putting in place the testing requirements, supporting the execution of these tests and summarizing the reports in compliance with your company’s design control system. 
 

Rigorous requirements are presented today with regard to the need to analyse the usability of your device, and with regard to the need to validate this usability through solid testing results. Furthermore, recent years have witnessed a growing emphasis on the need to gather the data obtained through Post Marketing Surveillance (PMS), and to analyse the potential implications of this data on the assessment of the safety and effectiveness of your device. HaMaDa specialists may help you in complying with these demands. 

Special Services may include:

 

  • US FDA Establishment Registration for Medical Device Companies

  • Preparing risk analysis management files (ISO 14971)

  • Specific performance test design

  • Shelf Life Testing including Accelerated Aging  

  • Usability Engineering File

  • UDI

  • Post Market Surveillance Plans

  • Personnel Training

  • Support for employee recruitment in the regulatory, QA and clinical fields


Due Diligence

 

Regulatory, clinical and quality due diligence audits for management, board members or investors of medical device companies.


We deliver a high level of audit capabilities based on a strong business orientation and advanced product development skills. Audits performed by HaMaDa can help uncover not only the regulatory, clinical and QA aspects of the audited company, but also the actual status of the developed product, regulatory submission and market. 


Training & Mentoring

HaMaDa provides customized quality and regulatory training. This can be ISO 13485 training for medical device companies or US FDA QSR training. We can develop on-site training programs for company employees on a variety of subjects concerning the design, development, manufacturing, testing and marketing of medical products. Sample training programs:

 

  • Introduction to Regulatory Affairs for medical devices

  • Quality System Principles- ISO 13485 establishment and implementation

  • Quality System inspection and audits- ISO 13485

  • FDA GMP Audits to QSR 21 Part 820 for Medical Device Companies

  • Preparing for an FDA Audit

  • Medical Device Risk Management- ISO 14971

  • Post-marketing requirements for medical devices  (EU Vigilance and 21CFR820)

  • Principles of Good Clinical Practice (GCP)

  • New and Updated Standards

                                                                    

Call us to discuss your specific needs  

+ 972.523.599.870