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 what are your target markets. 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.
Quality Assurance Services:
If you currently have a quality system in place, we can provide a complete review (gap analysis) of your system vis-à-vis applicable quality standards, such as the MDR requirements, ISO 13485 and QSR and support in executing the work plans.
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 aid in writing and developing specific processes and procedures to ensure quality system compliance.
- Drafting and Review of Quality Manual and Policy .
- Drafting Quality Objectives.
- Audits (Mock FDA, ISO 13485, ISO 27001, ISO 14155, MDSAP…).
- Assessing your list of applicable standards.
- SOPs development.
- SOPs review or adaptation .
- Gap Analysis and support in executing work plan (ISO 13485:2016, QSR, MDR…).
- MDR Gap Analysis and performing system upgrade.
- CAPA assistance.
- Assessment before transfer to production.
- Reviewing complaint system.
- Aid in Preparation of Management Review- presenting meaningful statistics.
- DHF – Establishment, Remediation in cooperation with the R&D team.
- Transfer to production quality and validation processes.
- Vendor remediation.
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.
Our team is expert in auditing: Quality audits, including ISO 13485, FDA GMP, and Notified Body inspections. Mock FDA audits, preparation for regulatory inspections and Clinical Studies Audits.
It is recommended to schedule an audit annually. Most commonly:
- ISO 13485 audit FDA GMP audits to QSR 21 Part 820
- Mock FDA audit
- Complementary internal audit for QA manager
- Subcontractor audits
Notified Bodies arrive for annual inspections as well as unannounced audits. We can provide audit services which will foresee any possible non-conformities that you may have and will help you to be prepared to address them in time.
When preparing yourself for compliance to FDA requirements or even in case you 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 in 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.
