Services
GAP ANALYSIS
Gap Analysis is done to formulate an action plan for up gradation of your Quality Management System.
Depending on the size of your organisation, complexity of your processes, classification of your products and status of your current certifications
TRAINING
Training have always been an integral part of the QMS. These new standards have emphasized more on training than ever before. All the new standards require all the stakeholders in the QMS to be trained on the new requirements.
DOCUMENTATION
Documentation requirements are changing. Since all new standards are more Risk Based and expect you to provide documentary evidence that Quality, Safety and Efficacy of the Medical device is ensured at all levels of the product development life cycle.
INTERNAL AUDITS
Internal audit works as the immunity system of your QMS. If it is effective, it enables you to identify Gaps long before they become non conformities. This way the proper CAPA plans can be developed and implemented at the right time to the right extent.
TECHNICAL FILE MANAGEMENT
All the applicable standards e.g. Risk Assessment, Clinical Evaluation, Post Marketing Surveillance, PMCF related to EN ISO13485:2016 and MDR 2017/745 requires the Technical Files to be regularly updated at defined intervals by qualified person/s.
VENDOR AUDITS
We provider complete vendor evaluation solutions by developing vendor evaluation plans and conducting on site and off- site reviews.
We also conduct supplier audits as per your quality standards and contractual requirements.