Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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  • The image shows a person wearing safety goggles and a lab coat working at a desk in a laboratory or engineering workspace. They are seated at a computer station with multiple monitors, typing on a keyboard while focusing on the screen. The desk is equipped with tools, documents, and a red organizer tray. The background features shelves and technical equipment, indicating a controlled, professional environment for research, development, or testing purposes.

    Writing Effective SOPs for Manufacturing Medical Devices

    Writing and implementing standard operating procedures (SOPs) for the manufacture of medical devices is required by ISO 13485, FDA, and other regulatory bodies. An SOP is a set of written instructions that documents a routine or repetitive activity that is followed by employees in an organization. The development and use of SOPs are integral parts of a successful quality system. They provide directions to perform a job properly and consistently to achieve predetermined specifications and quality end results. SOPs address all requirements to complete the job or process safely and effectively.

  • Quality Management Medical Device quality requires closed loop control

    Quality, what is it?

    Quality managers don’t have a magic wand to turn a bad product into a good one. Quality management needs an objective definition for quality.