Medical Device Consultants
Medical Device Consultants
Have you looked into using an experienced medical device consultants? What are some of the reasons to outsource regulatory medical device affairs?
Identifying regulatory expertise– to manage and ensure medical device products, experience matters to implement the right strategies can effect the following, delays to market, failed audits, products/devices that are not in compliance.
Medical Device Consultants– can handle multiple aspects no matter the stage you’re medical device products, pre-market review, product control, or post market surveillance. Core Compliance medical device consultants can provide and ensure compliance and develop strategies that represent your organization and regulatory compliance. Our consultants not only provide guidance but also provide training to your medical device organization. Eliminate the carrying costs of long term high paid employees.
Ensure compliance with a regulatory expert liaison– between your company and the contractor with Global regulatory/FDA regarding product clearance. Coordinate, prepare, and follow-up with international regulations substantial change notifications- defend your submission during the review process with and assist with securing market clearance or approval
Global International Regulatory Experience
Core Compliance has global international regulatory experience providing consulting services for medical device manufacturers, contract manufacturing, distributors, suppliers, laboratories and more across the globe.
Industries- Medical Devices, In Vitro Diagnostic Devices
Regulatory Markets We Serve
Americas- United States, Brazil Canada Columbia Mexico, EMEA (Europe, the Middle East and Africa) Egypt, Europe CE Mark, Asia Pacific, Australia, New Zealand , Peru, Russia ,Saudi Arabia ,South Africa, Turkey, China, Hong Kong, India, Singapore, South Korea, Taiwan.
Medical Device Consulting Services
Core Compliance provides medical device consulting services no matter the stage you’re medical device products pre-market review, product control, or post market surveillance our regulatory subject matter expertise can provide and ensure compliance.
- Education/Training-Changes and developments in the medical device industry
- Road Map-Construct a strategy to and outline framework to pre-market review, product control, or post market surveillance
- Conception & Development
- Establish Process & Procedures, Controls
- Documentation requirements-Identify, Design, implement
- Medical Device Product Control- Outline regulatory requirements
- Submission Management
- Manufacturing Facility- Inspection guidelines requirements
- Packaging/Complaint Handling- Identify Evaluate outline and create or change current procedures
- Software – Data management, Validation, Security
- Post-market surveillance-Outlined in the quality system requirements, internal auditing
Medical Device Conception & Development
Our medical device consultants provide medical device conception & development.
Service include, Identify design control ,and testing requirements (including verification, validation and clinical trials) Safety & performance best practices, risk management practices.
Establish Process & Procedures, Controls
Core Compliance consultants establish processes, procedures and controls that meet your medical device business vision, goals and FDA, International regulatory compliance.
- Legal Requirements- Identify Global and US legal requirements
- Process the legalization and authentication of registration documents
- Medical Device Reporting Procedures (MDR)
- CAPA Management – establish a CAPA procedure early as part of an overall Quality Management System 21 CFR 820:100
- Compliant Procedures- 21 CFR 820.198
- Non-Conforming Product Procedures
- Vendor establishment control- Vendor information facilitates governments in tracking medical device vendors
Documentation Requirements
Core Compliance medical device consultants will meet establish, design, and implement documentation requirements.
ISO Requirements-
Medical Device Products Requirements
Our regulatory consultants provide guidance for medical device products requirements, user needs, design input, design process, design output & validation.
- Design Control Guidance, classification, product registration & listing-
- Unique Device Identifier (UDI). Identifying mark used to distinguish devices from one another and make them easier to track Device Identifier (Type of device) Production Identifier- (serial number, expiration date, date of manufacture)
- Proposed device changes
Medical Device Submission Management
We provide medical device submission management including outlining requirements based upon medical device international regulatory requirements. Prepare and obtain certificates to foreign governments, Americas- United States, Brazil Canada Columbia Mexico, EMEA (Europe, the Middle East and Africa) Egypt, Europe CE Mark, Asia Pacific, Australia, New Zealand , Peru, Russia ,Saudi Arabia ,South Africa, Turkey, China, Hong Kong, India, Singapore, South Korea, Taiwan.
- Classification
- Registration/Approval
- Required Technical Documentation
- Conformity Assessment
- Declaration of conformity
Medical Device Manufacturing Facilities
Providing regulatory guidance for medical device manufacturing facilities.
- Inspection guidelines requirements- FDA Registration establishments or facilities) FDA requirements
- Non-Conforming devices form 483-(outlines and notifies management of any objectionable conditions found by FDA inspectors)
- CGMP– quality systems for FDA-regulated products (food, drugs, biologic, and devices) are known as current good manufacturing practices (CGMP’s)
Packaging Complaint Handling
Medical device consulting includes evaluating current procedures for packaging and labeling and create cGMP compliant regulatory requirements. Packaging and labeling to medical devices is a vital part of compliance to packaging systems in delivering clean, sterile and protected medical devices. External audit to identify packaging incidents or complaints.
Medical Device Software
Core Compliance evaluate the current state of compliance fir medical device software and provide the following services:
- Data management
- Validation Medical Device software-outline guidelines & recommendations
- Cyber-security and Risk Management processes.
Post-Market Surveillance
Core Compliance can handle all of the post market surveillance needs including:
- Support International Registrations for license renewals, product changes and/or new product launches
- Identify or Develop specific registration data information from applicable departments (R&D, Operations, QA, Medical,
- FDA/EU substantial change notifications
- Update technical files, as needed, with input from applicable departments
Represent Regulatory in product development projects by reviewing, approving, and completing requirements and coordinating team inputs for regulatory submissions. Compile and maintain regulatory documentation databases. Coordinate and respond to customer requests for product regulatory information.
ISO Standards
Core Compliance has expertise in the following ISO standards:
ISO 9001:2015 –Quality Management Systems
ISO 13485:2016 FDA Compliance 510K Submission CE Marking –Medical Devices Quality Management Systems
ISO 17025–Testing & Collaboration Laboratories Management
AS 9100–Aerospace Industry Quality Management Systems
ISO/IEC 20000:2011–Information Technology Service Management
ISO/IEC 27001:2011–Information Technology Security Management
R2:2013 RIOS Electronics Recycling NAID –Information Destruction e-Stewards –Responsible Recycling and Reuse of Electronics
ISO 14001– Environmental Management Systems
OHSAS 18001 ISO 45001 –Occupational Health & Safety Management
ISO/TS 16949-Automotive Industry Quality Management Systems
