SERVICES

MLR provides services in three broad categories described below.

                              (Click image to view client examples)

                      Medical / IVD                                   Product Development
 
  • ISO13485 and 21CFR 820 compliant device design
  • COGS evaluation; AVL audits and qualification
  • IP, Program, V&V, Risk plans
  • DFMEA, PFMEA, MMEA/HA
  • Design for assembly, manufacturability
  • PMA / PMN regulatory assistance
  • Clinical trial CTM production mgmt
  • Liaison to Automation contractors
  • Transition to manufacturing planning and liaison to contractors

 

          IP Creation & Management
 
  • Ideation workshops for broad-spectrum and targeted outputs, evaluation/scoring against rational criteria
  • Patent diligence/white-space mapping using semantic analyzers.
  • Assistance with patent drafting and portfolio management 
  • Ongoing surveillance of competitive patents and landscape positions 

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      Operations & Quality Planning
 
  • Drafting of ISO13485 and 21CFR 820 compliant QMS
  • Milestone and Gantt planning across all phases of the PDP
  • COGS planning and cost containment
  • IP Strategy for portfolio expansion
  • Early automation / packaging input to design
  • Manufacturing process development
  • Business context shifting and strategic alliances

MLR Associates LLC | 5 Oak Hill Road | Natick, Massachusetts 01760                            Tel. 617-877-1633                                                                                    mlrassocllc@gmail.com