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Project Examples: Operations & Quality Planning

MLR staff have been engaged with various clients developing
manufacturing lines with a variety of converting operations including:
  • Roll-to-roll primer/adhesive/release coatings (reverse roll, Mayer rod, slot)
  • Roll-to-roll slitting / laminating
  • High speed hot perforating, component feeding, and wrapping
  • Insert and two-shot injection molding 
  • Ultrasonic, impulse, laser, induction, & solvent bonding of thermoplastics
  • Non-woven and hydrogel material handling
  • Vacuum forming and thermoforming of commodity and specialty plastics / foams
  • High and low viscosity liquid delivery stations for microfluidic applications
  • In-line thermal and pad printing; Thermal transfer printing of conductive materials

MLR staff have drafted QMS documents for clients covering specific technical areas as well as consultants requiring flexible systems for use in varied engagements. These systems have been drafted to be compliant to 21CFR part 820 and the new ISO 13485: 2016.

We have assisted clients in the following business areas:
  • Intellectual property strategy and planning to maintain investor interest
  • Expansion of key stakeholders to include automation and packaging design input prior to design freeze
  • Forming strategic alliances for clients needing expansion of their business
  • Intensive COGS analyses and diligence prior to design control to confirm marketing expectations
  • Intensive design, process, and systems FMEA for clients to reduce their risk of failure
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