Medical Device Consulting Empowering Innovation from Concept to Commercialization

At OriPeutic BioServices, we partner with medical device innovators to navigate the complexities of development, compliance, and market access. From early-stage design through post-market surveillance, we deliver strategic, scalable solutions that help bring safe, effective, and high-quality technologies to life.

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Comprehensive Support Across the Medical Device Lifecycle

Our expert consultants work seamlessly with your team to accelerate innovation while ensuring regulatory alignment and operational efficiency. Whether you're building a Class I device or preparing a Class III PMA submission, OriPeutic delivers the insight, structure, and execution needed for success.

 

 

Bridging Engineering, Quality, and Compliance

Are you facing challenges in:

• Design control or risk management?

• FDA QSR or ISO 13485 compliance?

• Validation or regulatory documentation?

We’re here to help. OriPeutic BioServices combines deep technical knowledge, regulatory expertise, and real-world experience to guide your team through the design, development, and global commercialization process—while minimizing risks and avoiding delays.

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Our Core Medical Device Services

Product Development & Risk Management

• Design Control Frameworks aligned with ISO 14971

• Design History Files (DHF), Device Master Records (DMR), and Technical Files

• Risk analysis and mitigation strategy development

Regulatory Strategy & Submissions

• Regulatory pathway analysis (510(k), PMA, De Novo)

• FDA/Notified Body submission preparation and support

• Agency interaction planning and mock audits

Quality Systems & Validation

• QMS implementation and optimization (ISO 13485, FDA 21 CFR Part 820)

• Process and software validation, V&V protocol development

• Equipment qualification and documentation support

Post-Market & Compliance

• Post-market surveillance systems

• Complaint handling and CAPA process support

• Supplier audits and qualification

• Internal audit programs and readiness assessments

 

 

Sustainable Solutions That Strengthen Your Organization

At OriPeutic, we go beyond consulting—we embed ourselves in your process, mentor your teams, and leave lasting systems behind. Our goal is to help you not only achieve regulatory approval but also build operational capabilities that reduce compliance risk and improve product quality over the long term.