Disposable Syringe Manufacturing ProcessA Disposable syringe is a fundamental reacting siphon including an unclogged that fits solidly inside a round and empty chamber called a barrel. For needle producing unclogged can be legitimately pulled and pushed along inside the chamber, empowering the needle to take in and expel liquid or gas through a delivery opening at the frontContinue reading “How to start the Manufacturing of Disposable Syringes?”
Author Archives: operon strategist
Blood Collection Tubes Manufacturing
A Blood Collection Tube Manufacturing is of BCT/ Vacutainer which is a sterilized glass or plastic test tube with a coloured rubber stopper which creates a vacuum seal inside the tube supporting the draw of a fixed volume of liquid. It is also referred to as the “Vacutainer”. Vacutainer tubes consist of additives which are designed toContinue reading “Blood Collection Tubes Manufacturing”
Turnkey Project Consultants
As Turnkey Project Consultant, we work on complex technical problems and guide in planning the medical device manufacturing plant layout which is to reduce the client’s costs and the effort for observing, individual coordination and planning to a minimum. Medical Device Turnkey Project Consultants means that our clients will receive a total turnkey approach toContinue reading “Turnkey Project Consultants”
CDSCO Manufacturing license
Phases of CDSCO Manufacturing license Phase I – Applicant Registration Phase II – Test License application Phase III – Manufacturing license application Pre-requisite: Generic Name / Brand Name Intended Use Material of construction Mode of application The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to theContinue reading “CDSCO Manufacturing license”
ISO 15378 Certification Consultant
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 packaging material, forContinue reading “ISO 15378 Certification Consultant”
US FDA 21 CFR 820.30 Design Control Requirements
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”
CDSCO Import License for Medical Devices
Applicable when we have to import medical devices from other countries to India. However they need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in the countries. Operon Strategist assists pharma or medical device distributors and medical device wholesalers in India to procure CDSCO importContinue reading “CDSCO Import License for Medical Devices”
FDA 21 CFR Part 820 Quality system Regulation
FDA 21 CFR Part 820 covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labelling, storage, installation & servicing of medical devices. Manufacturers are inspected by the US FDA as per Part 820, however, there is no certification process for Part 820 & only compliance with the requirements is assessed.Continue reading “FDA 21 CFR Part 820 Quality system Regulation”
ISO 13485 Medical Device Certification
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 Medical Device Certification”
Medical Device Design and Development
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”
Medical devices consultancy 