This standard specifies the requirements for medical device industry related quality management system. Your organization is involved in design, manufacturing, installation, servicing or distribution of medical devices? ISO13485 applies to you.
- Requirements ISO13485 – 16 hrs
- ISO 13485 – Internal auditor (incl. requirements module) – 24 hrs
- Medical devices regulations training: MDR, MDD, CE Marking, MDSAP, FDA21CFR, JPAL, Cofepris…
- On-site, live/remote, or e-learnings
- Available in english, spanish and french
- Contact us to request the training programs!
- Quality management system audit / ISO13485 and applicable regulations
- Internal audits
- Supplier Audits
- Gap Assessments
- ISO13485, MDSAP, MDD, MDR, quality management system regulations.
- Technical documentation preparation for regulatory clearance.
Medical device regulations
For each country, where your organization is willing to provide its medical devices, your company has to meet the local regulations. Depending of the class of device as defined in the local regulation, you’ll need a full quality management system and review of your technical documentation by auditing organization or the regulatory authority itself.
SYMA Consulting is specialized in medical devices regulations and systems.
SYMA’s Consultants are actively working with notified bodies to keep their knowledge up to date.
Example of regulations
- México: COFEPRIS NOM 241, Registro sanitario
- USA: FDA GMP, 21 CFR part. 820, 510 k, MDSAP
- Canada, Japan, Australia, Brazil: MDSAP
- Europe: MDD 93/42/CEE, CE Marking, MDR – new Medical Devices Regulation
Local Registration Holder
- Mexican Registration Holder (partnership)
Other related subjects
- Risk Management ISO 14971
- Design controls for Medical Devices
- Effective corrective and preventive actions