Expertise in FDA medical device regulations, FDA manufacturing compliance and medical, 3D printing manufacturing consulting.
- Handle your FDA regulatory submissions and manufacturing compliance to keep your company in a continuous state of control.
- Manage quality systems and FDA regulations for your traditional manufactured and 3D printed medical products.
- Assist your manufacturing facility with FDA & ISO Audits.
- Vet and/or audit your foreign suppliers to assure FDA Quality compliance or adherence to ISO standards.
Just a few things we do well, every day:
FDA Regulatory & Compliance Consulting
Whether you’re manufacturing your medical products domestically or globally, FDA and other regulatory requirements must be in place and managed continuously to properly sell in the market. Guideline Medical has the ability to keep your regulatory and compliance systems updated and compliant to meet both domestic and global standards. The medical device industry is faced with ever changing regulations. It’s our job to assure your regulatory & compliance processes are meeting these changing demands.
- US FDA, EU and Canadian Regulatory Management
- Establishment Registrations (foreign or domestic)
- Device Classifications and Product Listings
- Pre-marketing Clearance 510(k) Submissions
- PMA Assistance
- CE Marking Assistance
- FDA Warning Letter and Form 483 Responses and Activities
- Import/Export Management: Product Hold Assistance
- FDA Labeling and Marketing Material Review
- US Agent for Foreign Medical and Pharma Facilities
- US and International Audits and Inspections of Medical Device Facilities
- ISO 13485:2016 Certification Services and Guidance
- Risk Management assessment, review and process development
- Gap Analysis of Manufacturing Quality Systems (Domestic/International)
- Development of QSR Manufacturing Process Manuals (items such as: DMR, Design and DHR SOPs)
- Development of Corrective and Preventative Action Procedures and Plans (CAPA)
- Post market Surveillance and Complaint Handling
- Sterilization Management & Microbiological Testing
- Quality System and Regulatory Training (cGMP, FDA QSR)
- Clean Room Validation
3D Printed Medical Device Services
Managing the production system of 3D printed devices is far more complicated than standard manufacturing practices. Aside from the complexity, FDA regulations tied to this technology are in a state of change.
Guideline Medical will help you successfully navigate this complexity by handling the FDA compliance and regulatory requirements needed to sell your 3D printed medical products.
The 3D Med-Make System
- Assess the entire 3D printing process
- Assist with 3D printing design review
- Assist with 3D printing process validation
- Develop FDA / QSR operating procedures
- Provide post production testing guidance
- Assist with 510k submission related to this new technology
Benefits to Your Company
- Assurance that your materials and processes are meeting FDA standards
- Assurance that your sterilization/cleaning processes are validated to FDA requirements
Our client profile
- Established medical device manufacturers who seek support managing FDA regulatory submissions, manufacturing compliance, and lack an in-house FDA authority.
- New medical device companies looking to set-up or expand FDA regulatory and compliance systems.
- Companies who need assistance with off-shore manufacturing compliance or medical component sourcing.
Safe T Surg, LLC
Guideline Medical brought our company into a state of regulatory control very quickly. Before Guideline Medical, we were looking for the right source to help build up our FDA regulatory documentation. Once Guideline Medical stepped-in, we were able to present our suppliers with a collection of quality documents written to FDA standards. Guideline Medical built our FDA Quality System Roadmap.
Kleenslate Concepts, LP
Guideline Medical manages our continual sourcing and manufacturing needs for highly regulated children’s and hospital patient products. They do a great job at managing the complicated systems of manufacturing, product testing and import logistics. Guideline Medical assures our products meet strict quality standards and they always have our best interests in mind. We’re confident about receiving safe, high quality products when Guideline is working on our behalf.
Julia Rhodes, CEO, KleenSlate Concepts
FTT Medical Manufacturing
Guideline Medical conducted a fast and accurate analysis of our quality system documentation. They provided us with useful and precise roadmaps that lead our factory to meeting ISO-13485 standards and registration.
The Guideline team helped us to develop a compliant Quality System Manual, they audited our systems for process compliance and assured our company was meeting both ISO and FDA standards. Guideline Medical was an asset to our team during the ISO 13485 audit and document development process. Our ISO 13485 registration has helped us expand our medical device manufacturing services and our national customer base.
John Longuil, CEO of FTT Medical Manufacturing (Geneseo, NY)
AccuMED Innovative Technologies
To prepare for a routine FDA investigation, Guideline Medical conducted a detailed analysis of our quality system documentation. They were able to quickly provide us with accurate information that enhanced our existing standard operating procedures. They worked closely with our QA team to prepare for positive outcomes from our FDA investigation.
