Advantu

MedTech Product Development and Manufacturing Qualification

Product Development – Mechanical/Electromechanical/Single Use Consumables

Jump to Qualification of Manufacturing Equipment

Medical Device Design

Advantu offers comprehensive design and development services from concept to launch – we bring deep expertise in design, development and manufacturing of medical devices, including ISO 13485 design controls and the ability to create a full DHF to support regulatory filings.

Phases

  • FeasibilityMedtech Product Development and Manufacturing Qualification
  • Design
  • Verification
  • Validation
  • Design Transfer

Advantu’s Capabilities

Product Development

  • Design and Development Planning
  • Human Factors & Usability Engineering
  • Proof of Concept
  • Prototype Development
  • Design Verification
  • Packaging Development
  • Sterilization Validation
  • Model and Drawing Creation
  • Supplier selection and evaluation
  • Material Selection
  • Product and Process Risk Evaluation
  • Transfer to Manufacturing

ManufacturingMedical Device Equipment Qualification

  • Process Qualifications
  • Production Efficiency
  • Production Cost Reductions
  • Manufacturing Line Transfers
  • Device Master Record (DMR) Transfer

Examples of typical projects:

  • Electronic Console/Instrument
    • Electroporation Instruments
    • Laparoscopic Instruments
    • Diagnostic Equipment
  • Laparoscopic devices- needle driver for suturing, trocars, bowel graspers 
  • Ultrasound wands
  • Heart Stabilizers
  • Drug Delivery devices
  • Multi Use Catheter- Cell and Drug delivery 

Advantu’s experts have delivered product development and manufacturing support for:

Qualification of Manufacturing Equipment

ManufacturingQualification of Manufacturing Equipment

  • Process Qualifications
    • Standard IQ, OQ and PQs
  • Production Efficiency
    • Lean Manufacturing
    • Time Studies
    • Reduction of Bottlenecks
    • Fixture/Equipment Development
  • Production Cost Reductions
    • Touch time efficiency
    • Design Optimization for Manufacturing (DFM)
  • Manufacturing Line Transfers
    • Duplication of production sites, transfer of production line for labor rate reduction
  • Device Master Record (DMR) Transfer
    • Full Documentation Preparation

“As  the CEO of a medical device company highly regulated by the FDA the responsibility of compliance and product integrity is at the absolute core of our business. The safety and protection of both the healthcare worker and their patients are absolutely critical and form the structure of all our planning and execution.’

‘After a long search we were able to secure John Rodriguez’s consulting expertise for our design, product and FDA compliance strategy and execution.’

‘Johns’ skills and experience go much wider than the brief he was given, and he offered us exceptional advice in ensuring that at each step of the commercialization of our products that we left no stone unturned in the design, engineering, manufacturing, assembly, packaging labeling and sterilization process.’

‘I can highly recommend John as a seasoned and highly value expert in his field and a “Master of His Art.’”

Peter Smith
CEO
Infusion Innovations Inc

Do you have a Product Development or Equipment Qualification Project on the Horizon?

Why Wait…

If you’re facing the following – let’s schedule a free consultation to discuss your priorities:

  • Looming product development project that can’t wait any longer
  • Equipment qualifications that have been put off due to resource/bandwidth issues

Here’s the good news – our experts have been helping teams address and resolve these issues for decades – let’s put our expertise to work for you.

For a free consultation – simply fill out the form below and hit Submit – we will schedule your consult today.  😀 

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