Looking for someone to provide operational guidance and strategy without adding a full time headcount? Let us add value by bringing proven, multi-disciplined, virtual executive experience to your organization. We fill fractional COO and other operations roles that best support your goals.
Building robust, scalable processes is core to any manufacturing organization. The overall production strategy (who, where, how) and the documentation that supports it can be an intricate dance of decisions. Providing guidance based on the complexity of your device, we can help mitigate foreseeable risks along the path to product acceptance.
The suppliers that any company involves in its supply chain are a crucial part of overall success. Relationships must be built and clear expectations set to drive scale. We can provide valuable insights into onboarding and maintaining critical suppler infrastructure.
Starting with user needs through product validation, we can assist with design reviews and risk assessment. Bringing in operations and manufacturing experience to improve design for manufacturability. We can also provide expertise in material selection, packaging, and labeling requirements.
Designing a lean QMS system that gives you the regulatory components that you need, but eliminates any excessive burdens is crucial for scalability. Let us help you design a more efficient process and audit the current system in place for FDA and ISO compliance.
Launching a new product, manufacturing line, or rollout of key processes? Let us help manage the timeline, objectives, budget, and KPIs to ensure it is successful.