QA & Regulatory Support

The QA function performs immensely critical duties in medical device companies which are all subjected to scrutiny by a variety of regulatory agencies. For many of them it becomes a do-or-die situation for sustenance of their business. This is more so because there is, unfortunately, a dearth of good, qualified and experienced people in the areas of QA.

We at Alceon can provide you with the support to maintain your QA and RA functions exactly as the regulatory agencies need them to be maintained. Our team has several experienced professionals overseen by an ex-Notified Body lead auditor and assessor!

Some of the areas where we can support you are:

Quality Objectives: setting appropriate objectives and indicators to monitor your processes, analysing data periodically and setting up dashboards for management to review
Internal Audit: conducting internal audits at pre-defined frequency
Data Analysis: analysing data trends that arise from various processes like manufacturing non-conformities, supplier performance, customer complaints, internal and external audits
CAPA: conducting root cause analysis and identifying effective corrective and preventive actions
Supplier Evaluations: conducting periodic supplier evaluations and supplier audits
Audit Response: preparing response to external audit non-conformances

We provide all these and more through an electronic quality system software (eQMS) platform. We have partnered with a Canadian vendor to provide a very affordable and versatile software platform that can track all your QA processes in a paperless way and keep all traceability intact. We set up the software and help you use it to run your QA processes not just efficiently but also effectively.