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WE OFFER CUSTOMIZED SOLUTIONS FOR YOUR MOST CRUCIAL PROJECTS

Medical devices, Pharmaceutical, Consulting, Contracting, Training, Quality, Engineering, Regulatory, Compliance, ISO, FDA, EU MDR

QUALITY

  • Design Control 

  • Risk Management

  • Quality Assurance 

  • Design Assurance 

  • Supplier Quality  

  • Post Market Surveillance 

  • CAPA

  • Quality Control

ENGINEERING

  • R&D 

  • Process Development 

  • Sustaining 

  • Line Support 

  • Verification & Validation

  • Equipment Specification
    & Installation

  • Software Validation  

  • Statistical Analysis

REGULATORY & COMPLIANCE

  • Auditing, Audit Preparation and Management 

  • Regulatory Submissions  

  • Inspection Readiness & Response Management

  • QMS Implementation
    & Remediation

  • EUMDR

  • MDSAP

  • HIPAA

OPERATIONAL EXCELLENCE IMPLEMENTATION

​

  • Forecasting & Planning 

  • Purchasing 

  • Incoming 

  • Manufacturing 

  • Mechanical test labs 

  • Testing stations &
    laboratories

  • Distribution 

SCIENTIFIC

  • LIMS Specialists 

  • Molecular Biology 

  • Laboratory Analysts 

  • Scientists 

  • Technical Writing 

  • Method Validation Specialists

  • Pharmacovigilance 

  • Drug safety

AREAS OF EXPERTISE

Our commitment to retain and grow talent has been key to our ongoing success. This has enabled MEC to continue to strengthen our internal and external training and support systems which further embeds the culture of excellence within the organization.

 

When a MEC resource commences a project, they bring this culture of excellence and MEC’s entire body of experience to our clients. Every MEC engineer has access to our full suite of internal resources from regulatory to project management. You are not just on-boarding a resource, you are on-boarding MEC’s guarantee of excellence.

TURNKEY PROJECTS

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Utilizing our broad functional and international expertise, MEC is the resource to handle site/line projects from scoping and planning through final commercialization.

Mapping current to future
state is critical to
remediation success.
Understanding thoroughly where you need to go allows MEC to plan and execute a seamless remediation of any current regulatory gaps.

Introducing new products and processes simultaneously requires careful planning and a deep understanding of both design controls and operational excellence. MEC leverages expertise from both of these environments which results in an optimal “design for manufacture” result.

Issues with suppliers and supply chain can be extremely costly.

From internal systems to vendor management, MEC will deliver a well-structured and executed vendor management system.

ACQUISITIONS

& TRANSFERS

QMS/

MANUFACTURING REMEDIATION

SUPPLIER 
MANAGEMENT

NEW PRODUCT
INTRODUCTION TO
COMMERCIALIZATION

CONNECT WITH US TO DISCOVER HOW
WE CAN HELP YOU REACH YOUR GOALS
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