|
The MicroMed Laboratories Group
of Consultants is a "One Stop" medical
device and biotech consulting service company
combined with expertise in training services.
MicroMed Laboratories’
Group of Consultants are selected to help our
clients in any phase of product development.
We give our clients extra time to concentrate
on the development, manufacturing and marketing
activities of their products. Whether your
company is a start-up or large company MicroMed
Laboratories’
group of consultants can help you with your compliance
and training.
Consulting Services
Design
Control
• Speed to Market Ensuring
Compliance
• Improved Product Quality
• Reduced Development and Product Launch
Costs
• Grow Product Sales Potential
• Identify International and Vertical
Markets
Laboratory
Consulting
• Cleaning Validation
and Analytical Testing (Verification)
• Equipment Qualification (IQ,OQ,PQ)
• Stability Program Design
• SOP Development
• Microbiology Testing
• Microbiology Consulting
• Biocompatibility Consulting
• Sterilization Validation Consulting
• Cleanroom CER Validations
• Comparative Studies
Pre-Certification Audits
• ISO 9001:2000 (ISO
9001:2008)
ISO 13485:2003
ISO 13485:2003 CMSCAS
CE Mark Certification
21 CFR 880 Compliance
Quality Management Systems-Requirements
Medical Devices-Quality Management Systems-Requirements for regulatory purposes
Management systems for medical device manufacturers
Regulatory
Affairs
• US, EU and OUS (non-EU)
Regulatory Strategies
• Interacting with EU
• OUS and U.S. Regulatory Documentation
• Pre-market Approvals (PMAs) and Post-Approval
Submissions
• Preparation of Clinical Documentation
• Global Regulatory, Clinical and Quality
Assurance
• EPA Pesticide Registration
Compliance
• Engineering Change
Orders
• Non-Conforming Materials Reports for
Manufacturing
• MDR Reporting and Cross-Reporting
• Regulatory Affairs Compliance Procedures
• GLPs, EU MDD and Design Control
Quality
Assurance
• Quality Systems (QSR,
ISO 13485 and ISO 9001:2000)
• Leading ISO Audits
• CAPA System Maintenance
• Change Orders
• Document Control and Vendor Approval
• Validation Protocols and Reports
• Quality System Audits
• Vendor Audits
• Compliance with QSR and ISO 9000
• Standard Operating Procedures and Implementation
Submission
Writing
• International Dossiers
and Amendments for Class IIa, IIb and III Products
• Class III PMAs: New Product Supplements,
30-Day Manufacturing
• 510k Notifications
• Drafting and Submission of an IND Application
• Communications with FDA
• Export Permit Requests
CE
Marking
• Technical Files Design
Dossier Preparation and Assessments
• Reorganize Files
• EC Authorized Representative Support
• CE Marking Procedure Kit
Product
Safety
• Product Safety Design
Support
• Test Agency Submissions
• U.L. Classification, CSA or TUV Approval
Consulting
Market Landscape & Opportunity
Assessments
• Conduct primary & secondary
research on target market situation revealing
key issues, trends & developments
• Conduct competitor intelligence
through investigation and analysis
• Identify COG requirements based
on reimbursement landscape
• Investigate device’s “marketability” and
intended use requirements
• Prepare Market Requirements
Definition (MRD) including market specifications,
customer performance requirements, clinical
applications and possible risks
• Value product and business
(market potential and financial analysis)
• Recommend optimal clinical
development plan
Product Positioning & Messaging
Strategy
• Develop product
positioning strategy in light of competitive
environment
• Create your business identity or “brand”
• Develop marketing messaging
Licensing & Partnership Strategy
• Develop and
evaluate partnership / acquisition strategies
to maximize program value.
• Identify and screen potential
candidates for partnership / acquisition (devices,
diagnostics, drugs, biologics)
• Conduct due diligence for potential
partner companies / products
|
