Services — MD&PC Medical Device & Pharmaceutical Consulting

Quality Management System Readiness

A strong Quality Management System is essential for maintaining regulatory compliance, supporting product quality, and ensuring operational efficiency in today's highly regulated medical device and pharmaceutical industries.

With more than 25 years of experience, Wayner provides practical, hands-on support for QMS development, remediation, compliance improvement, audit readiness, and process optimization. Whether your organization is preparing for an inspection, addressing compliance gaps, or strengthening quality processes, she can help you build a sustainable and inspection-ready quality system.

Supplier Management

Struggling with supplier quality issues, CMO oversight, or regulatory findings related to purchasing controls? Wayner helps medical device and pharmaceutical companies identify supply chain risks, strengthen supplier compliance, and implement effective quality management practices that support reliable product delivery.

With extensive experience in supplier quality, audits, and regulatory compliance, she provides practical, hands-on solutions focused on reducing risk, maintaining compliance, and protecting your business — whether you need short-term support or strategic quality guidance.

New Product Introductions

Successfully bringing a new medical device or pharmaceutical product to market requires effective coordination of regulatory strategy, quality systems, risk management, and cross-functional execution.

Wayner provides hands-on support for new product introduction activities — including regulatory planning, design and development support, QMS integration, supplier qualification, change management, and inspection readiness. Regulatory services include guidance for FDA and global compliance requirements, submission support, quality system remediation, audit preparation, and compliance strategy development.

Regulatory Submissions

Regulatory approval is one of the most critical milestones between product development and successful commercialization. Whether preparing for FDA submission requirements or supporting compliance with European regulations and applicable ISO standards, Wayner provides experienced, hands-on regulatory consulting tailored to the medical device and pharmaceutical industries.

She assists companies with submission strategy, preparation and review of submission documentation, assessment of verification and validation data, and evaluation of supporting technical information — ensuring submissions are complete, compliant, and inspection-ready while protecting your competitive advantage.

Audit-Ready Compliance Documentation

Clear, accurate, and well-organized documentation is essential for successful regulatory inspections, audits, and product submissions. Backed by more than 25 years of regulatory, quality, and audit experience, Wayner provides practical support for the development and remediation of audit-ready compliance documentation.

Specialized expertise includes the preparation and review of documents that clearly communicate technical and regulatory content to auditors, health authorities, and subject matter experts — while minimizing redundancies, inconsistencies, and compliance gaps. Support spans QMS compliance, regulatory submissions, post-market changes, design control deliverables, validation activities, risk management, and supplier quality.

FDA & ISO Quality System Training

Effective quality system training is essential for maintaining compliance, supporting successful audits, and ensuring consistent execution of procedures across an organization. Wayner provides practical, industry-focused training on FDA Quality Management System Regulation (QSR) requirements, ISO 13485, and core QMS processes.

Training services help employees understand not only "what to do," but how to confidently communicate and demonstrate compliance during audits and inspections. Offerings include customized training materials, quality system training programs, audit preparation coaching, and targeted instruction on design controls, CAPA, supplier management, document controls, risk management, and validation requirements.

Product Lifecycle Management (PLM)

Disorganized information, missing design documentation, and limited access to critical product data can create significant operational, regulatory, and compliance risks. Fragmented systems and institutional knowledge trapped within individual experts lead to duplicated work, delayed change management, audit findings, and inefficient product support.

Wayner provides practical PLM support focused on improving the organization, accessibility, and integration of critical product and quality information — connecting data, documents, business processes, and quality system requirements into a more efficient and compliant framework. The goal is to establish "One Source of Truth": a reliable, centralized approach to managing product knowledge that supports design controls, change management, manufacturing, audit readiness, and long-term product support.

MD&PC is here to help you manage your regulatory and quality system requirements