Author Archives: operon strategist

Many see a  QMS (quality management system) certification as the necessary thing for a medical device company – something you should have so as to be compliant. A QMS certification is a regulatory requirement that the FDA (Food and Drug Administration) or the ISO auditors state as basic. It improves the product quality and wellbeing and guarantees ISO and FDA agreement.Continue reading “QMS Certification training for medical devices”

A validation master plan (VMP) diagrams the standards associated with the capability of an office, characterizing the areas and systems to be approved, and gives a composed program for achieving and keeping up a certified facility. Master plans are composed to help an association with approval methodologies or to provide control over a particular procedure. Validation, anyContinue reading “Validation Master Plan (VMP)”

ISO 15378 Certification is a quality assurance for primary packaging materials for medical products specific prerequisites for the utilization of ISO 9001:2008, with reference to GMP. In 2006, the procedure-oriented ISO 15378 standard was delivered. In view of the globally acknowledged ISO 9001 quality standard, it contains all the GMP essentials appropriate to primary packagingContinue reading “Operon strategist provide consultancy for ISO 15378 Certification”

Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications.

This is an example post, originally published as part of Blogging University. Enroll in one of our ten programs, and start your blog right. You’re going to publish a post today. Don’t worry about how your blog looks. Don’t worry if you haven’t given it a name yet, or you’re feeling overwhelmed. Just click theContinue reading “Introduce Yourself (Example Post)”