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ISO 13485 Certification — Quality Management for Medical Devices

ISO 13485 Certification — Quality Management for Medical Devices

Santé & PharmaciePharmacie & Dispositifs médicaux
Manufacturing or distributing medical devices requires a strict and traceable quality system. We structure your ISO 13485:2016 certification (linked to CE medical marking): gap analysis, design control, ISO 14971 risk management, technical file, post-market surveillance, mock audit then certification. Team of senior consultants, health regulatory experts. Quote within 48 hours.
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Consulting · C2 — ISO Certifications

ISO 13485 Certification — Quality Management for Medical Devices

Without ISO 13485, it is impossible to manufacture, distribute or export medical devices: it is the prerequisite for CE marking and the requirement of health clients in Morocco and internationally.

Results commitmentSenior consultantsMorocco & AfricaQuote within 48h
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ISO 13485 Certification — Quality Management for Medical Devices — support from TargetUp Morocco & AfricaTargetUp Consulting — Morocco & Africa
The programme

Presentation

ISO 13485 gap analysis, structuring of the quality system (design and development control, risk management according to ISO 14971, technical file, traceability, post-market surveillance), internal audit and mock audit, followed by support until the certifying body audit.

Why TargetUp: contractual result guarantee, triple expertise in Consulting + Financing + Training under one roof, team of senior consultants (average of 20 years of cumulative experience), rooted in Morocco & French-speaking Africa.

👉 Request a quote or free consultation: book your 30-minute complimentary 360° flash diagnosis, with no obligation.

TargetUp Support

Support provided by senior consultants

Executives, quality managers, R&D and operators subject to normative requirements or market access

20+
years of expertise
4
offices Morocco & Africa
48h
for your quote
Why TargetUp

A recognised consulting partner

Sectoral Expertise

Senior consultants who understand your business and your standards.

Anchoring Morocco & Africa

A thorough understanding of the local regulatory and economic context.

Result commitment

A reinforced obligation of means, marked and contractualised.

Proven method

A structured Lean approach: frame, measure, improve, sustain.

Skills transfer

Your teams become autonomous in the process.

Accreditation Network

A recognised ecosystem of certifications and affiliations.

Frequently asked questions

You may be wondering…

What is the cost of this support?
Pricing is established based on a quote, according to your context and scope. Request your quote below: response within 48 hours.
Do you operate throughout Africa?
Yes. We support organisations in Morocco and several Francophone African countries, both in-person and remotely.
How do you get started?
An initial scoping exchange (free) allows us to qualify your needs and propose an adapted approach.

Request your quote

Fill out this form: a TargetUp consultant will contact you within 48 hours with a tailored proposal.

Your requestConsulting — C2 — ISO CertificationsISO 13485 Certification — Medical Device Quality Management

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