Author Archives: operon strategist

IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION Medical devices have a vital role in providing better diagnosis, prevention, Screening, monitoring, and treatment of various diseases. The COVID -19 pandemic challenge has shown the necessity to have accurate diagnostics and a stringent framework for the in vitro medical devices (IVDs). IVDs are biological tests that can detectContinue reading “EUROPEAN IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION”

As ISO 13485 consultant we provide guidance about QMS for medical device industries and we make sure that our clients know the benefits of ISO 13485 Certification for their organization. ISO 13485 Certification Quality Management System for Medical Device Industries ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes which isContinue reading “ISO 13485 Consultant | Certification – Operon Strategist”

Quality Management Systems (QMS) certification is the requirement of every business processes who need to comply with an arrangement of complex and challenging regulatory requirements. Operon Strategist has substantial experience in regulatory areas required for QMS certification implementation of medical devices, in vitro diagnostic devices, packaging material products, pharmaceuticals products and combination products. QMS certification is anContinue reading “QMS certification For Medical Devices”

FDA 21 CFR Part 820.30 design control is the most important stage in the advancement of a medical device since a defective plan may prompt it being inadequate or dangerous (that is, not affirmed or cleared by the administrative organization). At the design stage, an outline design control process should be started and actualized as a feature of the QualityContinue reading “US FDA 21 CFR 820.30 Design Control Requirements”

A successful and safe medical device development is an essential element of any medical device manufacturer. Developing the right medical device needs repetition of processes to ensure the quality of the device to prevent the future risk of failure of the product. A medical device company strives hard to improve and meet stringent regulatory requirementsContinue reading “Corrective Action Request with Medical Device Suppliers”

The prerequisites for MDR classification for medical devices are basically equivalent to those in the present Medical Devices Directive (MDD). The EU MDR is shaking up the medical device industry and the order rules have not been left immaculate. The MDR decides the congruity assessment course for the device. While the order principally worries of the maker,Continue reading “MDD to New MDR Classification of Medical Devices”

Medical Device Design and Development and a vital role in making the medical device which meets the quality expectations at par and may not lead to the customer complaints and failure in the market. The routes cause of most of the customer complaints, recalls, device failures are the poor medical device design and development activity. AnyContinue reading “Medical Device Design and Development”

Design And Development Consultant – Combination Products Combination product as indicated by the Central of Federal Regulation CFR is expressed as a product that includes a medical device /or a medication/or a biologic consolidating any two of these classifications and at some point even every one of the three. The well-known term of combination product isContinue reading “Design And Development Consultant – Combination Products”