Med-Sherpa
med-sherpa is a highly experienced regulatory and quality management service provider for small and medium-sized medical device manufacturers. Headquartered in New Hampshire with employees across the country, they assist clients in achieving regulatory compliance and establishing effective Quality Management Systems. Their principles include safety, compliance, conformance, high efficiency, fair pricing, and transparency. They operate as autonomous 'Consultractors,' offering tailored, risk-based solutions and handling tasks such as scoping, chartering, resourcing, daily management, progress tracking, and reporting. They provide a range of services including regulatory affairs, design and development support, verification and validation, product launch preparation, ongoing post-market surveillance, operational support, initiation strategies, and more. Their team comprises experienced professionals with backgrounds in project management, regulatory compliance, international registration, risk management, and other specialties. The leadership team includes Nathan Dowd, General Manager and Co-Owner, and Peter Nickerson, Advisor and Co-Owner. Contact information includes an address at 169 Daniel Webster Highway, Suite 135, Nashua, NH 03060, email info@med-sherpa.com, and phone number 303.332.4627.
Industries
Nr. of Employees
small (1-50)
Med-Sherpa
169 Daniel Webster Highway, Suite 135, Nashua, NH 03060
Services
Fractional regulatory affairs support for recurring activities, lifecycle maintenance, technical file updates, and ad-hoc regulatory tasks delivered as-needed.
ISO 13485 gap assessments and QMS development or upgrades to align processes, records, and controls with regulatory expectations.
Support for design input/output definition, specifications, drawings, manufacturing instructions, software development plans, and risk management initiation.
Planning and execution of engineering/bench verification and validation activities and preparation of formal V&V test reports.
Design and execution of PMS plans, adverse event/vigilance reporting, complaint handling, trending, PSUR/PMSR preparation, and PMCF support.
Supplier reviews, corrective action support, and drafting/negotiation of supplier- and customer-facing quality agreements.
Fractional regulatory affairs support for recurring activities, lifecycle maintenance, technical file updates, and ad-hoc regulatory tasks delivered as-needed.
ISO 13485 gap assessments and QMS development or upgrades to align processes, records, and controls with regulatory expectations.
Support for design input/output definition, specifications, drawings, manufacturing instructions, software development plans, and risk management initiation.
Planning and execution of engineering/bench verification and validation activities and preparation of formal V&V test reports.
Design and execution of PMS plans, adverse event/vigilance reporting, complaint handling, trending, PSUR/PMSR preparation, and PMCF support.
Supplier reviews, corrective action support, and drafting/negotiation of supplier- and customer-facing quality agreements.
Expertise Areas
- Regulatory compliance and submissions
- Quality management system implementation (ISO 13485)
- Design controls and product development
- Risk management (ISO 14971, FMEA/FTA)
Key Technologies
- Design history file (DHF) and technical documentation
- FMEA and fault tree analysis (FTA)
- IQ/OQ/PQ process validation
- Engineering/bench verification and V&V test planning