Med Device Manufacturing | DISCUS Software | FDA 21 CFR Part 820Medical device manufacturers are often faced with unique challenges.  According to the FDA, the organization that oversees med device production, 44% of device recalls derive from faulty design.  Recalls are embarrassing, expensive and often avoidable.  They result in serious financial consequences from the FDA and possibly from the judicial system or unhappy shareholders. DISCUS Software is a quality software that can provide inspection forms with valuable information that could reduce these consequences.

The med device manufacturing landscape is ultra-competitive and always evolving.  Ensuring that your process includes a quality system that works from the initial design of the product through component selection, manufacturing, use and disposal is paramount.

The Top 4 Obstacles for Med Device Manufacturers

  1. Payers and Providers Power Shift: The traditional business model in healthcare is clinician’s choice.  Today, however providers and payers are self-evaluating med devices based on efficiency and safety as well as value and budget.
  2. Increasing Cost of Compliance and Intensified Regulatory Scrutiny: FDA audits have increased by 40% and the cost of corporate compliance has risen nearly 5 times over the past decade.  Med device recalls are typically damaging and high-profile.
  3. Lack of Innovation: Regulatory issues and high upfront costs and often cause med device manufactures to focus their research and development on enhancements to already approved devices.  Often these improvements are more feasible than developing new innovations.  For startups, funding sources are often hard to target and engage.
  4. The Digital Shift: All med device manufacturers are faced with the challenge of moving from paper-based to paperless manufacturing.  Because of the cost, quality, regulatory, and supply chain benefits this shift is a necessity.

How DISCUS Software Can Help

21 CFR Part 820 | Inspection Sheet | Med Device Manufacturing

DISCUS products assist manufacturing and quality engineers with all the facets of device inspection planning and documentation production.  DISCUS enables a user to view a drawing or model and quickly identify the inspection characteristics and extract the characteristic requirements.  This identification can then be used to efficiently create manufacturing and quality assurance compliance reports.

DISCUS Software can also:

  • Flag missing requirements and then allow you to easily add them in logical sequence
  • Automatically create professional and customizable reports that are impressive for first pass inspections.
  • Eliminate recalls while improving your reporting process and saving your company resources.

Med device manufacturers that place strategic investments into electronic/software driven systems have faster and better compliance practices. Recognizing the time-consuming nature of the record-keeping for the Device Master Record (DMR) and Device History Record (DHR), manufacturers benefit by using software like DISCUS. In addition, the FDA Adverse Event database contains literally thousands of incidents where device manufacturers have encountered issues due to poor device design requirement identification, inspection planning and inspection documentation.

DISCUS products assist manufacturing and quality engineers with all the facets of device inspection planning and documentation production.  DISCUS enables a user to view a drawing or model and quickly identify the inspection characteristics and extract the characteristic requirements.