SOP Development

Build a Compliant, Scalable Quality System

Standard Operating Procedures (SOPs) are the backbone of any compliant and consistent medical device development process. At PulseForward, we specialize in creating clear, actionable, and audit-ready SOPs aligned with global regulatory standards including ISO 13485, ISO 14971, IEC 62304, IEC 60601, and FDA QSR requirements. Whether you're building from the ground up or refining an existing quality system, our SOP development services ensure you’re prepared for audits, inspections, and long-term success.

What We Deliver:

• Custom SOP Creation – Tailored to your company’s size, structure, product types, and development model. We avoid boilerplate and build processes that actually work.

• Regulatory Alignment – SOPs mapped to ISO standards, FDA guidance, EU MDR/IVDR, and best practices across risk, software, design controls, and cybersecurity.

• Document Hierarchy & Template Development – Creation of a quality manual, procedure templates, work instructions, and forms to create a scalable system.

• Gap Assessments & Remediation – Identify missing, outdated, or non-compliant procedures and update them to meet current requirements.

• Team Training & Implementation Support – Workshops and guidance to ensure your teams understand and can execute new procedures effectively.

Why PulseForward?

Our approach is practical. We don’t just write SOPs—we build operational systems that enable your teams to move faster while staying compliant. With deep knowledge of technical documentation, design controls, software lifecycle processes, and risk management, we deliver SOPs that auditors respect and your team can follow.