Apsis Consulting Group
Tel. 475-237-7994
54 State Street, STE 804 #8573
Albany, New York 12207
What We Provide
A Right-Sized QMS
Setting up a Quality Management System can feel daunting if you're unsure how much you need. We guide you towards a lean setup that works for your team.
eQMS Platform Setup
Vendor evaluation and system configuration for your team
Design Control Setup
Design and manufacturing file organization DHR, DHF, DMR
ISO 13485 Ready
Complete system setup aligned to global standards and FDA QSR
Internal Audit
Ongoing monitoring and audits to maintain compliance
We design and implement a practical, right-sized QMS SOP set and, when needed, stand up your eQMS so quality fits the way you actually build product.
What this includes
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Core ISO 13485 / 21 CFR 820 procedures: document control, design controls (820.30), risk management (ISO 14971), CAPA, supplier management, complaints, internal audits, and training.
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eQMS startup: vendor evaluation, configuration with our implementation partners, migration of key records, and basic workflows (change control, approvals, training).
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Templates and structure for DHF, DMR, DHR and change control, plus rollout support (training and a clear “Day 1 vs Phase 2” implementation plan).
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If you already have some quality processes, we assess how well they align with 21 CFR 820 and ISO 13485 and convert that into a prioritized, founder-friendly gap list.
What this includes
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Clause-by-clause review of your SOPs and key records (DHF/DMR/DHR, complaints, CAPA, supplier files, training).
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A gap matrix that ranks findings by regulatory and business risk (inspection-critical vs “improve later”).
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A practical remediation roadmap with owners, sequencing, and quick wins that reduce exposure without freezing development.
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We help you build an internal audit program that is predictable, useful, and inspection-defensible, even if you don’t yet have trained auditors.
What this includes
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Design of a risk-based internal audit plan aligned to ISO 13485 / QSR expectations.
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Execution of mock FDA / ISO audits with clear grading of observations and linkage into CAPA.
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Coaching and simple tools so your team can eventually run effective audits in-house, not just once a year in panic mode.
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When you need senior QA judgment but can’t yet justify a full-time Director plus staff, fractional leadership gives you a standing quality owner on a flexible basis.
What this includes
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Acting as your de facto QA lead/Management Representative for ISO 13485: quality planning, management review inputs, and key approvals.
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Ongoing oversight of design controls, risk files, DHF/DMR/DHR, CAPA, KPI dashboard for leadership and investors.
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Regular working sessions (weekly/bi-weekly) and on-call support for decisions and emerging issues—structured as month-to-month, unlimited advisory within agreed response times, so you can scale up or down as your team grows.
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