Medical Devices

Quality Assurance & Quality Control Solutions for Medical Devices

The quality and reliability of Medical Devices is essential to guarantee patient safety and to the growing needs of healthcare practitioners and healthcare systems.

Global Wits Consultancy Services has been supporting the industry in reaching high standards of quality of medical devices with a large range of reliable and efficient quality solutions. As a globally trusted quality assurance and quality control services company, we follow the latest international medical regulations and standards to help our clients bring safer products to the market and secure their global supply chain.

Our range of quality assurance and quality control services for medical devices has been designed to answer the industry’s core needs; for example, improving factory performance, ensuring the reliability of medical manufacturers, implementing a quality management system, preparing to certification (ISO 13485, ISO 11137, GMP 21 QSR 820…), and controlling medical product quality.

Our Industries & Applications

Global Wits Consultancy Services provides quality control services for medical devices from Class I, Class II and Class III, and our experience comprises the following product categories:

• In vitro diagnostics
• Medical, surgical and dental instruments.
• Powered / wireless / connected medical devices
• Medical furniture
• Needles/catheters and cannulae
• Ophthalmological products

• Orthopaedic devices
• Medical imaging machines
• Medical Implants
• Surgical Masks/Personal Protective Equipment (PPE)
• And many more

Our Quality Assurance and Quality Control Services

Supplier Management

Benefit from our expertise to improve and optimize your supply chain performance.

• Manufacturing Process Audits
• Process Improvement
• Production Capacity Analysis (Run & Rate)
• Quality Investigation (root cause investigation of defective product)
• Root Cause Analysis
• Corrective Action Follow up
• Process Failure Mode Effects Analysis (PFMEA)
• Medical Device File Validation
• APQP/PPAP assistance for Medical Device
• Continuous Improvement

Enhance Supplier Performance with Global Wits Consultancy Services’s Comprehensive Supplier Management Toolkit

Buyers, procurement managers and quality managers play a vital role in ensuring supplier quality. This encompasses proactive performance monitoring to identify and mitigate costly risks and errors.

Global Wits Consultancy Services offers a robust set of services to ensure supplier quality, which we call the Supplier Management Toolkit. The toolkit is designed to help anyone managing supplier quality to navigate the challenges of meeting supplier compliance and quality standards and delivering quality products.

Our stage-based Sourcing Lifecycle applies to virtually any product or component, guiding you from new product development to outgoing QC and shipment.

Below, we outline each stage of the sourcing journey and highlight the common risks and challenges faced in supplier management, helping you safeguard your supply chain and uphold your brand’s reputation.

Development & Planning;

 1. New Product Development

New product development lays the foundation for strategic sourcing. Prototyping is crucial to validate that the supplier understands the client’s requirements.

Global Wits Consultancy Services inspections validate the new parts while our supplier development services align quality expectations with suppliers and strengthen their ability to meet quality requirements and reduce time to market.

Global Wits Consultancy Services’s Quality Solutions:

 First Article Inspection (FAI)
 Supplier Development Services
 Resident Supplier Quality Resourcing

Supplier Risks & Challenges:

 Poor communication of technical details between buyers and factories
 Misalignment of product specifications and critical design requirements among buyers, suppliers, and factory production teams
 Inadequate consideration of advanced product quality planning
 Challenges when transitioning from prototype suppliers to mass-manufacturing suppliers
 Misalignment on design and engineering revisions

 2. Supplier Selection

Once the component specifications are defined, the procurement department identifies a list of suitable suppliers that can potentially meet their capability, cost, capacity, and quality requirements.

Global Wits Consultancy Services offers a range of supplier due diligence and supplier evaluation support. Our experts visit suppliers to assess their capabilities, mitigate the risk of scams, overpromises, and miscommunication, and validate their credentials, trustworthiness, and financial stability.

Global Wits Consultancy Services’s Quality Solutions:

 Supplier Quality Audits
 QHSE Audits
 ESG Audits
 Onsite Supplier Verification
 Financial Credit Check

Supplier Risks & Challenges:

 Lack of experience and due diligence in new supplier region
 Communication challenges
 Concern about supplier scams
 Low confidence supplier’s trustworthiness
 Concerns over supplier’s financial viability

 3. Supplier Qualification

A world-class organization usually has a comprehensive supplier qualification program to identify and mitigate the risks associated with quality, safety, on-time delivery, cost, and compliance.

Global Wits Consultancy Services establishes a global audit program to systematically onboard new suppliers, categorize their risk levels, and establish a reaction plan based on the supplier’s performance on quality systems, environmental management, and social and ethical compliance.

Global Wits Consultancy Services’s Quality Solutions:

 Global Supplier Audit Programs
 Supplier Quality Audit for Potential Suppliers
 Quality Management System Audit
 Social & Ethical Audits
 Supply Chain Security Audit
 Environmental Audit

Supplier Risks & Challenges:

 Suppliers are not as capable as they initially claimed
 Supplier lacks effective and systematic quality assurance practice
 Supplier is ISO 9001 certified, but the underlying principles are not implemented in practice
 Mass production quality does not match prototype quality
 Buyers want to sell to big retailers, but their suppliers do not yet comply with the retailer’s supplier code of conduct
 Supplier violation on labor law, ethical and environmental compliances
 Goods held in customs due to supply chain security malpractice

 4. Pre-Production Validation

Before commencing volume production, it is crucial to validate that the equipment, staffing, production methods, capacity, and quality control plan are in place for each product line.

Global Wits Consultancy Services offers on-site quality support to prevent and reduce the potential cost of poor quality (COPQ) and risk, ensuring a smooth transition from product development to mass production.

Global Wits Consultancy Services’s Quality Solutions:

 Engineering Build (EB) and Quality Build (QB) Audit
 First Article Inspection (FAI)
 APQP/PPAP Audit
 Manufacturing Process Audit
 Resident Supplier Quality Resourcing

Supplier Risks & Challenges:

 Factory not ready for mass production
 Shipment delays due to critical failure, poor quality, and resource constraints
 An exponential increase in defective products
 Product recall
 High Cost of Poor Quality
 An exponential increase in the cost of change after mass production commences

Production & Delivery

 5. Production Planning

Production planning ensures that the supplier has sufficient raw materials, components, and staff and that other outsourced processes meet the specified schedule.

Global Wits Consultancy Services offers assistance in timely supplier communication, onsite visits, and daily or weekly monitoring reports. This minimizes the risks of delays from ineffective procurement planning, staff shortages, or sub-supplier mismanagement.

Global Wits Consultancy Services’s Quality Solutions:

 Order Expediting
 Resident Supplier Quality Resourcing

Supplier Risks & Challenges:

 Production delay due to poor material procurement planning
 Production delay due to inadequate production staffing
 Poor sub-supplier management

 6. Incoming Quality Control

Incoming inspection reflects a factory's commitment to quality control from the outset. Understanding how a factory manages its incoming material and its supply chain is a very good indication of its commitment to quality.

Global Wits Consultancy Services quality solutions address issues such as defect acceptance, material substitutions, and component decay due to poor practices or storage conditions.

Global Wits Consultancy Services’s Quality Solutions:

 Incoming Inspection
 In-Process Inspection
 Manufacturing Process Audit

Supplier Risks & Challenges:

 The factory does not manage the quality of its supply chain or is poor at supplier management
 Suppliers turn a blind eye to defective components during incoming and still use them for production and assembly
 Using sub-standard material or components (e.g., lower-quality fabric than required)
 Substituting lower-cost alternatives for product components (e.g., cheaper electronic components in a mobile phone)
 “Quality fade” where suppliers make small, gradual substitutions in materials and components over time
 Bulk material ordered by the supplier degrades over time due to poor storage conditions

 7. Production and Assembly

Many things can go wrong during mass production due to machine failure, lack of process control, and operator mistakes. While it is normal for defects to occur, these defects must be detected and contained.

Global Wits Consultancy Services offers a range of support to verify control plan adherence, early defect detection, quality improvement, and issue resolution through monitoring, investigations, and CAPA validation.

Global Wits Consultancy Services’s Quality Solutions:

•  First Article Inspection (FAI)
•  In-Process Inspection
•  Manufacturing Process Improvement
•  Quality/Root Cause Investigation (8D)
•  CAPA Verification
•  Order Expediting
•  End-Of-Line Testing & inspection
•  Resident Supplier Quality Resourcing

Supplier Risks & Challenges:

 Operators are not producing according to the production control plan
 Supplier is under pressure to ship goods, turning a blind eye to defective components
 Lack of quality staff to enforce quality control
 Poor control of re-worked material/product
 Mistakes made by temporary, untrained staff/operators
 Communication breakdown when the supplier is under pressure

 8. Outgoing QC & Shipping

The smallest aesthetic defect on the packaging or missing components can lead to customer returns, while a misplaced label may result in compliance issues. Outgoing Quality Control is the last line of defense before products are properly loaded into containers for shipment.

Global Wits Consultancy Services offers pre-shipment inspections and end-of-line testing to ensure your products meet your quality requirements and reduce the chance of returns or re-work.

Global Wits Consultancy Services’s Quality Solutions:

 Manufacturing Process Audit

•  Poka-Yoke Implementation
•  Pre-Shipment Inspection
•  End-Of-Line Testing & inspection
•  Container Loading Supervision
•  C-TPAT Audit

Supplier Risks & Challenges:

 Products are poorly packaged
 Human mistakes and missing components lead to customer returns
 Wrong labeling leads to compliance issues and significant re-work
 Rough handling of goods during container loading by the factory or outsourced warehouse, leading to damaged product
 Poor container loading leads to product damage during transit

Why Global Wits Consultancy Services?

Partnership

Global Wits Consultancy Services genuinely sees your company and your suppliers as partners looking for growth and improvement. We don’t just give pass/fail results. We provide professional recommendations, facilitation, and performance management to achieve the desired results.

Quality Dashboard

Global Wits Consultancy Services’s Quality Dashboard provides a holistic dashboard view of your supplier portfolio including data analytics to better understand and determine the next action required at your supplier.

Experience & Expertise

Global Wits Consultancy Services has overseen successful supplier transformation projects helping companies from the packaging industry achieve their quality goals.

Global Presence

Global Wits Consultancy Services has agile teams of inspectors and auditors a lot of countries ready to meet your quality assurance needs whether it’s a packaging quality inspection or a comprehensive factory audit.