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Medical

Precision Solutions for Medical Device Manufacturing

Hole Specialists, Inc. is an industry leader in gun drilling, deep hole drilling, pull bore, trepan, and honing services since 1993. At Hole Specialists, Inc., we combine these core capabilities with state-of-the-art equipment, rigorous quality control, and decades of expertise to deliver superior results for our clients. Our comprehensive quality management system ensure consistent excellence across all services.

Core Manufacturing Capabilities

Gun Drilling
Excellence

Gun Drilling Excellence

  • Surgical instrument components
  • Medical device parts
  • Implant components
  • Diagnostic equipment
  • Custom instrumentation
  • Prototype development
  • Process optimization
  • Validation support

Deep Hole Drilling Specialization

  • Large equipment components
  • Imaging system parts
  • Treatment delivery systems
  • Custom applications
  • Production tooling
  • Prototype services
  • Equipment modification
  • Validation services 

Advanced Precision Services

  • Component straightening
  • Precision alignment
  • CNC turning
  • Trepanning services
  • Custom machining
  • Production support
  • Tool development
  • Process optimization

Medical Industry Quality Standards

Quality System Certifications

  • ISO 13485:2016 compliance
  • FDA registration
  • GMP standards
  • Process validation
  • Quality documentation
  • Material traceability
  • Inspection protocols

Regulatory
Compliance

Regulatory Compliance

  • FDA compliance
  • CE marking support
  • Quality system regulation
  • 21 CFR Part 820
  • Risk management
  • Process validation
  • Design controls
  • Document control

Documentation & Traceability

  • Material certification
  • Process validation
  • Inspection records
  • Sterilization validation
  • Biocompatibility data
  • DHR/DMR support
  • Complete lot traceability
  • Quality documentation

Technical Specifications for Medical Applications

Precision Parameters

  • Hole diameters: 0.078″ to 24.000″
  • Depths up to 480 inches
  • Straightness: 0.001″ per foot
  • Surface finish to 16 RMS
  • Position tolerance: ±0.001″
  • Custom specifications
  • Clean room capability
  • Validation support 

Material Processing Capabilities

  • Medical grade stainless
  • Titanium alloys
  • Cobalt chrome
  • Medical plastics
  • Biocompatible materials
  • Custom materials
  • Specialty alloys
  • Validated processes

Medical Industry Project Experience

Surgical Instruments

  • Precision components
  • Custom instruments
  • Specialized tooling
  • Production support
  • Process development
  • Quality control
  • Validation support
  • Documentation

Medical Devices

  • Component manufacturing
  • System assemblies
  • Custom fixtures
  • Production support
  • Prototype services
  • Testing equipment
  • Process improvement
  • Validation services

Diagnostic Equipment

  • Precision components
  • System parts
  • Custom solutions
  • Prototype development
  • Production support
  • Process improvement
  • Quality control
  • Validation support

Production Support Services

Process Development

  • Manufacturing engineering
  • Tool design
  • Fixture development
  • Process optimization
  • Production planning
  • Quality planning
  • Documentation support
  • Training programs 

Production Capabilities

  • Clean room manufacturing
  • Validated processes
  • Inventory management
  • Production scheduling
  • Process monitoring
  • Quality control
  • Statistical analysis
  • Continuous improvement

Technical Support

  • Engineering consultation
  • Design assistance
  • Material selection
  • Process optimization
  • Problem solving
  • Quality planning
  • Documentation support
  • Validation assistance

Advanced Quality Control

Inspection Equipment

  • CMM measurement Digital inspection tools
  • Surface analysis
  • Bioburden testing
  • Custom gauging
  • In-process inspection
  • Final verification
  • Documentation systems

Testing Capabilities

  • Sterility testing
  • Material verification
  • Performance testing
  • Environmental testing
  • Quality validation
  • Process capability
  • Statistical analysis
  • Documentation

Production Management

Project Management

  • Dedicated program managers
  • Schedule tracking
  • Progress reporting
  • Quality monitoring
  • Documentation management
  • Timeline adherence
  • Cost control
  • Risk management

Inventory Control

  • Clean room storage
  • Material tracking
  • Stock management
  • Emergency stock
  • Sterile packaging
  • Packaging validation
  • Logistics support
  • Storage solutions 

Value-Added Services

Engineering Support

  • Design for manufacturability
  • Process optimization
  • Material selection
  • Cost reduction
  • Quality improvement
  • Problem solving
  • Documentation support
  • Validation support

Quality System Support

  • Quality system development
  • Validation protocols
  • Documentation support
  • Regulatory compliance
  • Risk management
  • Process validation
  • Training programs
  • Audit support

Medical Industry Experience

OEM Support

  • Major manufacturer approval
  • Production experience
  • Quality system compliance
  • Process development
  • Documentation support
  • Program management
  • Cost control
  • Timeline adherence

Research Support

  • Prototype development
  • Custom solutions
  • Process support
  • Quality control
  • Documentation
  • Technical support
  • Validation support
  • Regulatory guidance

Contact Information for Medical Projects

Production Inquiries

Primary Contact: Medical Program Director

Location & Facilities

27950 Commercial Park Road Tomball, TX 77375

  • Production facility
  • Quality lab
  • Engineering center
  • Shipping & receiving
  • Customer support
  • Technical center

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