NB request (demand) for change of scope (MDSAP) post surveillance audit

overandownunder

Registered
Hi all, would appreciate any information, experiences or talking points on the subject below-

We are a Class I/II Orthopaedic implant (Sterile/Non-sterile) manufacturer in Australia. Participate in MDSAP- Had a surveillance audit Nov 2023 w/ extension of scope (sterile). Our scope currently (The design, development and manufacture of orthopaedic implants, instruments and accessories for use in extremities) is being demanded mid 3 year re-cert cycle to be more specified/changed, wanting to detail non-sterile and specific extremity which would not cover the full range of our products and activities that we currently work with; noting that it is too restrictive, such that it would not let us continue the current legitimate design, development and manufacturing of our product ranges.
During Audit, it was agreed that we would discuss with NB at re-cert a change in scope that would best resolve all concerns but until that time, current scope is sufficient.

MDSAP Certification Scope -NB is specifically stating, "FDA specific guidance is that the scope for orthopedics manufacturers should be at the specific level, such as “knee implant system, canulated bone screws, spinal fixation devices” and ideally should use GMDN terminology."

Have a call in 5 days to discuss concerns etc. with NB. Any talking points, information or guidance (good/bad) would be most appreciative. Thanks all
 

E-Amen

Registered
Maybe its too late... but how did your call with NB go and did you resolve the scope situation. Curious to know.
 

overandownunder

Registered
Maybe its too late... but how did your call with NB go and did you resolve the scope situation. Curious to know.
NB/AO - communications are still ongoing in terms agreeing on scope that will not eliminate portions of the business. Also in talks with another AO to take current scope and actually work with us instead of against us.
 
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