Regulatory, Clinical & Quality Affairs for the MedTech Industry

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

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Establishing, Implementing and Auditing Quality Systems

Medical device companies are usually required to have a quality system in place as part of the process of getting your product to market. This can be ISO 13485 compliant and/or FDA QSR compliant and more, depending on who your target markets are. What’s important is setting up and maintaining an effective quality system that fits your organizational structure. HaMaDa provides you the ability to establish such a QMS. 

 

If you currently have a quality system in place, we can provide a complete review of your system vis-à-vis applicable quality standards, such as QSR and ISO 13485.

 

Personalized service ensures that your procedures or quality systems are designed, developed and implemented, together with your teams, and in accordance with your specific needs. Our quality system implementation consultants can aid in writing and developing specific SOPs to ensure quality system compliance.


Quality audits are critical in order to validate and improve on the system implemented at your site, or at essential sub-contractor sites. We perform quality audits encompassing the entire quality system process or focused on specific areas, such as design controls, traceability, complaint system, process validation, etc. These audits are meant to help your company remain compliant with regulatory requirements and quality systems.

It is recommended to schedule an audit annually. Most commonly:

  • Mock FDA Audit

  • ISO 13485 Audit FDA GMP Audits to QSR 21 Part 820

  • Complementary internal audit for QA manager

  • Subcontractor audits

 

Notified Bodies come for annual inspections and unannounced audits. We can provide audit services which will foresee any possible non-conformities that you may have and will help you in being prepared to address them in time. 


When preparing yourself for compliance to FDA requirements or even receive notification that the FDA is coming for an inspection, we can provide your company with the help needed in order to prepare for the FDA audit not only by running a mock audit but breaking down tasks, providing a detailed timeline, completing the tasks necessary to make sure you are in compliance as well as training your staff for proper audit conduct.

 

As your regulatory partner, when violations are uncovered, we are there to provide recommendations for corrective actions and to formulate practical solutions for responding to findings, QA Audits, FDA 483 forms, FDA warning letters, Notified Body non-compliance reports, etc. We will also identify and provide assistance in implementing all of the steps necessary to correct violations, particularly resolution of underlying quality system problems. Services available include:

 

  • Mock Audits (FDA, ISO 13485 and others)

  • SOPs development

  • SOPs review

  • ISO 13485:2016 gap analysis and support in executing work plan

  • CAPA assistance 

  • Assessment before transfer to production

  • Reviewing complaint system

  • Drafting and Review of Quality Manual and Policy 

  • Assessing your list of applicable standards

  • Aid in Preparation for Management Review- presenting meaningful statistics

  • Drafting Quality Objectives    

And more