Medical Device Consultants

Have you looked into using 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 your 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 your 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 evaluates the current state of compliance for medical device software and provides 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