Services
Consulting
Whether it is your first approach to the endless world of the medical industry, you need help understanding how to apply a certain standard, or you simply don’t have the resources to do it, ALPA Medical was created to offer the help you always wanted but found hard to find.
We can help with any task associated with your product(s) or quality system, giving you the information you need in a friendly, pragmatic way. From the usual “does this standard apply to us?”, to the more general “how do I CE mark my product?”, through to “I want to be certified under MDSAP, what do I need to do?”, we have it covered. No more burdensome documents, no more non-value-adding steps, and no more infinite loops that take you nowhere. That is a promise.
ALPA Medical has the skills and technical experience to take your company from A to B in the most efficient way, explaining the reasons why and tailoring each step to your needs.
- Direct with a senior lead auditor You work with Alberto himself, with no account managers and no hand-offs.
- Pragmatic, not paperwork Practical guidance that removes the unnecessary documentation burden.
- Tailored to you Every step is tailored to your product(s) and your quality system.
Our expertise
We can help you with the following
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CE Marking (Europe)
Full MDR preparation, including the extended Article 120 transitional timelines. Legacy CE certificates remain valid to 31 December 2027 for Class III and Class IIb implantable devices, and to 31 December 2028 for other Class IIb, Class IIa and Class Is, Im and Ir devices, subject to the eligibility conditions.
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MDSAP (Brazil, Canada, USA, Japan, Australia)
Full preparation and registration
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Technical Documentation
Construction, review and gap analysis
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Quality System
Gap analysis; writing of procedures, forms and work instructions; process-approach simplification; full set-up of a Quality Management System
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Risk Management
Establishment of a Risk Management File; review and analysis of the entire RMF; correlation of the RMF with applicable standards
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Auditing
Internal audits (first party); supplier audits (second party); certification body audits (third party); mock unannounced audits; mock MDSAP audits; targeted process audits; overview and gap analysis; remediation projects
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Training
See the training section for more information
Get in touch
Not sure where to start?
Ask the awkward first question, “does this standard apply to us?”, and we’ll take it from there, tailoring each step to your needs.