A medical device consulting team that helps organizations improve and enhance their quality management system (QMS) procedures and practices. We ensure our QMS procedures fully comply with medical device FDA regulations and ISO 13485 standards, but are also easily understood, and therefore followed and implemented by staff.
Based on over 35 years experience working with a range of companies, from Fortune 200 to start ups in the Medical Device and Pharmaceutical industry, we provide:
• out-of-the-box SOP’s that can be quickly and easily tailored to your specific business.
• out-of-the-box templates, forms and work instructions to help educate your staff
• implementation support – training your employees on the implementation of these procedures and documents
• best practises recommendations – to minimize your exposure to receiving warnings during audits.
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